Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors

NCTNCT00831844Other idNCI-2009-01170Other idNCI-2009-01170Other idCDR0000633186Other idCOG-ADVL0821

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names IGF-1 (mecasermin), does not test it. It appears in the title.

Overview

Status: Completed
Phase: Phase 2
Enrollment: 116 participants (actual)
Sponsor: National Cancer Institute (NCI) · Nih
Design: Not randomized · Open label (no masking)
Countries: 3 countries
United States, Australia, Canada
Start: Jan 2009
Primary completion: Apr 2013
Completion: Oct 2013
First posted: 29 Jan 2009 (estimated)
Last update posted: 30 Mar 2015 (estimated)
Conditions: Adult Rhabdomyosarcoma · Adult Synovial Sarcoma · Childhood Hepatoblastoma · Childhood Synovial Sarcoma · Previously Treated Childhood Rhabdomyosarcoma · Recurrent Adrenocortical Carcinoma · Recurrent Adult Soft Tissue Sarcoma · Recurrent Childhood Liver Cancer · Recurrent Childhood Rhabdomyosarcoma · Recurrent Childhood Soft Tissue Sarcoma · Recurrent Ewing Sarcoma/Peripheral Primitive · Neuroectodermal Tumor · Recurrent Neuroblastoma · Recurrent Osteosarcoma · Recurrent Retinoblastoma · Recurrent Wilms Tumor and Other Childhood Kidney Tumors

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200920102011201220132014

Ph 2
Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors
NCT00831844
Jan 2009 to Oct 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This phase II trial is studying the side effects and how well cixutumumab works in treating patients with relapsed or refractory solid tumors. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

Interventions

cixutumumabBiological
laboratory biomarker analysisOther

Arms10

Experimental
Group 1 - Recurrent or Refractory Hepatoblastoma
Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Experimental
Group 2 - Recurrent or Refractory Synovial Sarcoma
Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Experimental
Group 3 - Recurrent or Refractory Rhabdomyosarcoma
Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Experimental
Grp 4-Recurrent or Refractory Adrenocortical Carcinoma
Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Experimental
Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Experimental
Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease
Group 6 - Recurrent or Refractory Neuroblastoma -meta-iodobenzylguanidine (MIBG) Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Experimental
Grp 7-Neuroblastoma with measurable disease
Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Experimental
Group 8 - Recurrent Osteosarcoma
Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Experimental
Group 9 - Recurrent or Refractory Wilms Tumor
Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Experimental
Group 10 - Recurrent or Refractory Retinoblastoma
Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Primary outcomes1

Outcomes the sponsor listed as primary.

Disease Response
Time frame · First six treatment cycles - 24 weeks
Registry description
Response rates will be calculated as the percent of patients whose best response is a Complete Response (CR) or Partial Response (PR).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· First six treatment cycles - 24 weeks

Disease Response

Group	Value (patient)
Group 1 - Recurrent or Refractory Hepatoblastoma	10
Group 2 - Recurrent or Refractory Synovial Sarcoma	10
Group 3 - Recurrent or Refractory Rhabdomyosarcoma	19
Grp 4-Recurrent or Refractory Adrenocortical Carcinoma	10
Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor	11
Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease	16
Grp 7-Neuroblastoma With Measurable Disease	10
Group 8 - Recurrent Osteosarcoma	9
Group 9 - Recurrent or Refractory Wilms Tumor	9
Group 10 - Recurrent or Refractory Retinoblastoma	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Group 1 - Recurrent or Refractory HepatoblastomaGroup 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	–	7 / 10	5 / 10
Group 2 - Recurrent or Refractory Synovial SarcomaGroup 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	–	3 / 10	7 / 10
Group 3 - Recurrent or Refractory RhabdomyosarcomaGroup 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	–	4 / 20	14 / 20
Grp 4-Recurrent or Refractory Adrenocortical CarcinomaGroup 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	–	5 / 10	5 / 10
Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorGroup 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	–	5 / 13	8 / 13
Grp 6 - Neuroblastoma-MIBG Positive Without Measurable DiseaseGroup 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	–	5 / 20	9 / 20
Grp 7-Neuroblastoma With Measurable DiseaseGroup 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	–	4 / 10	9 / 10
Group 8 - Recurrent OsteosarcomaGroup 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	–	4 / 9	5 / 9
Group 9 - Recurrent or Refractory Wilms TumorGroup 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	–	5 / 9	9 / 9
Group 10 - Recurrent or Refractory RetinoblastomaGroup 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies	–	0 / 0	0 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 7 Months up to 30 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Histologically confirmed malignant solid tumor, including the following: * Osteosarcoma * Ewing sarcoma/peripheral primitive neuroectodermal tumor * Rhabdomyosarcoma * Neuroblastoma * Wilms tumor * Synovial sarcoma * Hepatoblastoma * Adrenocortical carcinoma * Retinoblastoma * No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists * Radiographically measurable disease\*, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by MRI or CT scan or ≥ 10 mm by spiral CT scan * The following are not considered measurable disease: * Ascites, pleural effusions, or other malignant fluid collections * Bone marrow infiltration by tumor * Lesions detected only by non-MIBG nuclear medicine studies (e.g., bone scan) * Previously irradiated lesions that have not demonstrated clear progression post-radiotherapy * No known Central Nervous System (CNS) metastases unless they were treated by surgery or radiotherapy AND are stable with no recurrent lesions for ≥ 3 months * Lansky or Karnofsky performance status (PS) 50-100% OR Eastern Cooperative Oncology Group (ECOG) PS 0-2 * Absolute neutrophil count (ANC) ≥ 1,000/mm³ (\> 250/mm³ for patients with neuroblastoma) * Platelet count ≥ 75,000/mm³ (\> 25,000/mm³ for patients with neuroblastoma) (transfusion independent) * Hemoglobin ≥ 8.0 g/dL (≥ 7.5 g/dL for patients with neuroblastoma) (RBC transfusion allowed) * Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine normal based on age/gender as follows: * ≤ 0.4 mg/dL (for patients 1 to 5 months of age) * ≤ 0.5 mg/dL (for patients 6 to 11 months of age) * ≤ 0.6 mg/dL (for patients 1 year of age) * ≤ 0.8 mg/dL (for patients 2 to 5 years of age) * ≤ 1 mg/dL (for patients 6 to 9 years of age) * ≤ 1.2 mg/dL (for patients 10 to 12 years of age) * ≤ 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age) * ≤ 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients ≥ 16 years of age) * Total bilirubin ≤ 1.5 times upper limit of normal for age * Alanine transaminase (ALT) ≤ 110 U/L * Serum albumin ≥ 2 g/dL * Blood glucose normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * Able to comply with safety monitoring requirements of study * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to study drug * No uncontrolled infection * No known type I or II diabetes mellitus * Recovered from prior chemotherapy, immunotherapy, or radiotherapy * More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) * At least 7 days since prior hematopoietic growth factors (14 days for pegfilgrastim) * At least 6 weeks since prior monoclonal antibody therapy * At least 7 days since other prior antineoplastic biologic agents * No prior monoclonal antibody targeting the IGF-IR * No prior small molecule kinase inhibitors of IGF-IR * At least 2 weeks since prior local palliative (small port) radiotherapy * At least 3 months since prior total-body irradiation, craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis * At least 6 weeks since other prior substantial bone marrow radiotherapy * At least 2 months since prior stem cell transplantation * No evidence of graft-versus-host disease * Concurrent corticosteroids allowed provided dose is stable or decreasing over the past 7 days * Intermittent use of corticosteroids to manage infusional reactions allowed * No other concurrent anticancer therapy, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy * No other concurrent investigational agents * No concurrent insulin or growth hormone therapy

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