Trial · Interventional

CompletedNot applicableResults postedRegistry data

Radiosurgery in Treating Patients With Kidney Tumors

NCTNCT00458484Other idCASE12806Other idP30CA043703Other idCASE12806Other idNCI-2010-01064

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names MIF-1 (Pro-Leu-Gly-NH2), does not test it. It appears in the description.

Overview

Status: Completed
Phase: Not applicable
Enrollment: 31 participants (actual)
Sponsor: Case Comprehensive Cancer Center · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: 20 Feb 2007
Primary completion: 12 Mar 2017
Completion: 12 Sept 2019
First posted: 11 Apr 2007 (estimated)
Last update posted: 22 Jul 2020
Conditions: Kidney Cancer

Timeline

1 trial · 1 completed · 1 with posted results

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

201020152020

N/A
Radiosurgery in Treating Patients With Kidney Tumors
NCT00458484
20 Feb 2007 to 12 Sept 2019

Registry summary

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

RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I/II trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery.

Interventions

stereotactic radiosurgeryRadiation
Renal BiopsyProcedure
Serum Blood MarkersProcedure

Arms2

Experimental
Series 1: Stereotactic radiosurgery
Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.
Experimental
Series 2: Stereotactic radiosurgery
Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.

Primary outcomes1

Outcomes the sponsor listed as primary.

Maximum Tolerated Dose of Radiosurgery
Time frame · once every 4 weeks
Registry description
Dose escalation stops if 2/4 (50%) or 3/8 (37.5%) of participants experience DLTs in a given dose level cohort. The maximum tolerated dose will be one dose level below which the DLTs were exceeded.

Secondary outcomes(4)

Overall Survival
Time frame · at 36 months from start of therapy
Registry description
Radiographic efficacy as measured by overall (percent of participants still alive after study completion)
Progression-free Survival
Time frame · at 36 months from start of therapy
Registry description
Percent of participants still alive and without tumor progression at study completion
Freedom From Local Progression
Time frame · at 36 months from start of therapy
Registry description
Radiographic efficacy as measured as measured by freedom from local progression (percent of participants without local progression or local recurrence after study completion)
Freedom to Distant Recurrence
Time frame · at 36 months from start of therapy
Registry description
Radiographic efficacy as measured by distant recurrance (percent of participants without distant failure after study completion)

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· once every 4 weeks

Maximum Tolerated Dose of Radiosurgery

Group	Value (Gy)
Series 1: Stereotactic Radiosurgery	48
Series 2: Stereotactic Radiosurgery	60

Secondary and other outcome results(4)

Secondary outcomeNumber· at 36 months from start of therapy

Overall Survival

Group	Value (percentage of participants)
Series 1/Dose Level 1: Stereotactic Radiosurgery	75
Series 1/Dose Level 2: Stereotactic Radiosurgery	100
Series 1/Dose Level 3: Stereotactic Radiosurgery	33
Series 1/Dose Level 4: Stereotactic Radiosurgery	66
Series 2/Dose Level 1: Stereotactic Radiosurgery	66
Series 2/Dose Level 2: Stereotactic Radiosurgery	100
Series 2/Dose Level 3: Stereotactic Radiosurgery	66

Secondary outcomeNumber· at 36 months from start of therapy

Progression-free Survival

Group	Value (percentage of participants)
Series 1/Dose Level 1: Stereotactic Radiosurgery	75
Series 1/Dose Level 2: Stereotactic Radiosurgery	100
Series 1/Dose Level 3: Stereotactic Radiosurgery	33
Series 1/Dose Level 4: Stereotactic Radiosurgery	66
Series 2/Dose Level 1: Stereotactic Radiosurgery	33
Series 2/Dose Level 2: Stereotactic Radiosurgery	100
Series 2/Dose Level 3: Stereotactic Radiosurgery	66

Secondary outcomeNumber· at 36 months from start of therapy

Freedom From Local Progression

Group	Value (percent)
Series 1/Dose Level 1: Stereotactic Radiosurgery	100
Series 1/Dose Level 2: Stereotactic Radiosurgery	100
Series 1/Dose Level 3: Stereotactic Radiosurgery	100
Series 1/Dose Level 4: Stereotactic Radiosurgery	100
Series 2/Dose Level 1: Stereotactic Radiosurgery	100
Series 2/Dose Level 2: Stereotactic Radiosurgery	100
Series 2/Dose Level 3: Stereotactic Radiosurgery	66

Secondary outcomeNumber· at 36 months from start of therapy

Freedom to Distant Recurrence

Group	Value (percent)
Series 1/Dose Level 1: Stereotactic Radiosurgery	100
Series 1/Dose Level 2: Stereotactic Radiosurgery	100
Series 1/Dose Level 3: Stereotactic Radiosurgery	100
Series 1/Dose Level 4: Stereotactic Radiosurgery	100
Series 2/Dose Level 1: Stereotactic Radiosurgery	75
Series 2/Dose Level 2: Stereotactic Radiosurgery	100
Series 2/Dose Level 3: Stereotactic Radiosurgery	100

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Series 1/Dose Level 1: Stereotactic RadiosurgeryDose Level I: Radiation will be delivered in 4 fractions: 6 Gy x 4 fractions: Total of 24 Gy Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance. Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.	1 / 4	2 / 4	0 / 4
Series 1/Dose Level 2: Stereotactic RadiosurgeryDose Level 2: Radiation will be delivered in 4 fractions: 8 Gy x 4 fractions: Total of 32 Gy	0 / 6	1 / 6	1 / 6
Series 1/Dose Level 3: Stereotactic RadiosurgeryDose Level 3: Radiation will be delivered in 4 fractions: 10 Gy x 4 fractions: Total of 40 Gy	1 / 3	1 / 3	0 / 3
Series 1/Dose Level 4: Stereotactic RadiosurgeryDose Level 4: Radiation will be delivered in 4 fractions: 12 Gy x 4 fractions: Total of 48 Gy	2 / 6	3 / 6	1 / 6
Series 2/Dose Level 1: Stereotactic RadiosurgeryDose Level I: Radiation will be delivered in 3 fractions: 16 Gy X 3 fractions: Total of 48 Gy Renal Biopsy: At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance. Serum Blood Markers: ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.	1 / 4	3 / 4	1 / 4
Series 2/Dose Level 2: Stereotactic RadiosurgeryDose Level 2: Radiation will be delivered in 3 fractions: 18 Gy X 3 fractions: Total of 54 Gy	0 / 4	1 / 4	3 / 4
Series 2/Dose Level 3: Stereotactic RadiosurgeryDose Level 3: Radiation will be delivered in 3 fractions: 20 Gy X 3 fractions: Total of 6 Gy	0 / 3	1 / 3	2 / 3

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 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Patient is considered a poor surgical candidate for removal of renal mass as determined by anesthesiology pre-operative assessment or the surgical team, medical team. (No major psychiatric illnesses.) * Patient is able to give and sign study specific informed consent * No prior radiation to the treatment field * Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential * Patient has a radiologically and /or pathologically confirmed diagnosis of a renal tumor * Karnofsky status of ≥ 60% * Signed study-specific informed consent prior to study entry Exclusion Criteria: * Any patient not meeting the eligibility criteria. * Any patient with active connective tissue disease such as lupus, dermatomyositis. * Any patient with active Crohn's disease or active ulcerative colitis. * Major psychiatric illness, which would prevent completion of treatment or interfere with follow-up.

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