Expired Study
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Indianapolis, Indiana 46202


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have metastatic or unresectable kidney cancer.


Study summary:

OBJECTIVES: - Determine the overall response rate and overall and disease-free survival of patients with unresectable or metastatic renal cell cancer treated with fludarabine and cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation. - Determine the toxicity and treatment-related mortality of this regimen in these patients. - Determine the percentage of donor chimerism in patients treated with this regimen.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed renal cell carcinoma (RCC) - Clear cell or papillary RCC - Granular tumors with sarcomatoid features - No purely sarcomatoid RCC, chromophobic RCC, or oncocytoma - No transitional cell carcinoma of the renal pelvis and collecting systems - Metastatic or unresectable disease - At least 1 measurable lesion - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - The following are not considered measurable: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Lymphangitis cutis/pulmonis - Abdominal masses that are not confirmed and followed by imaging techniques - Cystic lesions - Primary bladder masses - Progressive disease after interferon alfa and/or interleukin-2 for metastatic RCC OR intolerance to these therapies - No prior or concurrent CNS metastases - Negative MRI of the brain within the past 28 days - Must have HLA-identical (6/6) sibling donor PATIENT CHARACTERISTICS: Age: - 60 and under Performance status: - ECOG 0-1 Life expectancy: - More than 6 months Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST no greater than 3 times ULN Renal: - Creatinine clearance at least 40 mL/min Cardiovascular: - LVEF at least 45% by MUGA or echocardiogram Pulmonary: - DLCO greater than 40% of predicted (corrected for hemoglobin level) - No symptomatic pulmonary disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No known hypersensitivity to E. coli-derived products - No uncontrolled diabetes mellitus - No active serious infection - No other concurrent malignancy except non-melanoma skin cancer or other malignancy that has less than a 30% risk of relapse after completion of therapy PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No concurrent sargramostim (GM-CSF) - Concurrent epoetin alfa allowed Chemotherapy: - No other concurrent chemotherapy Endocrine therapy: - At least 28 days since prior hormonal therapy (e.g., megestrol, corticosteroids, or anti-estrogen therapy) - Concurrent steroids allowed for adrenal failure, graft-versus-host disease, or other nondisease-related conditions (e.g., insulin for diabetes) Radiotherapy: - At least 14 days since prior radiotherapy Surgery: - At least 14 days since prior surgery Other: - At least 28 days since prior systemic therapy for RCC - Recovered from prior therapy


Study is Available At:


Original ID:

CALGB-90003


NCT ID:

NCT00027573


Secondary ID:

U10CA031946


Study Acronym:


Brief Title:

Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer


Official Title:

Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Alliance for Clinical Trials in Oncology


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

36


Enrollment Type:

Actual


Overall Contact Information

Official Name:Brian I. Rini, MD
Study Chair
University of California, San Francisco

Study Dates

Start Date:October 2001
Completion Date:June 2006
Completion Type:Actual
Primary Completion Date:June 2006
Primary Completion Type:Actual
Verification Date:July 2016
Last Changed Date:July 12, 2016
First Received Date:December 7, 2001

Study Outcomes

Outcome Type:Primary Outcome
Measure:Overall response rate
Time Frame:Up to 5 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Overall survival
Time Frame:Up to 5 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Disease-free survival
Time Frame:Up to 5 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Treatment-related mortality
Time Frame:Up to 5 years
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Percentage of donor chimerism in patients treated
Time Frame:Up to 5 years
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:filgrastim
Arm Name:Chemotherapy + stem cell transplantation
Intervention Type:Biological
Name:therapeutic allogeneic lymphocytes
Arm Name:Chemotherapy + stem cell transplantation
Intervention Type:Drug
Name:cyclophosphamide
Arm Name:Chemotherapy + stem cell transplantation
Intervention Type:Drug
Name:fludarabine phosphate
Arm Name:Chemotherapy + stem cell transplantation
Intervention Type:Drug
Name:methotrexate
Arm Name:Chemotherapy + stem cell transplantation
Intervention Type:Drug
Name:tacrolimus
Arm Name:Chemotherapy + stem cell transplantation
Intervention Type:Procedure
Name:peripheral blood stem cell transplantation
Arm Name:Chemotherapy + stem cell transplantation

Study Arms

Study Arm Type:Experimental
Arm Name:Chemotherapy + stem cell transplantation
Description:Patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1-2 hours on days -4 and -3. Allogeneic peripheral blood stem cells are infused on day 0. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 5 and continuing until blood counts recover. Patients receive graft-versus-host disease (GVHD) prophylaxis comprising oral tacrolimus twice daily on days -1 to 90 and methotrexate IV on days 1, 3, and 6. After day 120, patients with pe

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Alliance for Clinical Trials in Oncology
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Rini BI, Halabi S, Barrier R, Margolin KA, Avigan D, Logan T, Stadler WM, McCarthy PL, Linker CA, Small EJ; Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; Southwestern Oncology Group. Adoptive immunotherapy by allogeneic stem cell transplantation for metastatic renal cell carcinoma: a CALGB intergroup phase II study. Biol Blood Marrow Transplant. 2006 Jul;12(7):778-85.
PMID:16785067

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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