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

NCT00027573 | Completed Phase 2

• 3 other identifiers: CALGB-90003U10CA031946CDR0000069044
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer; recurrent renal cell cancer; clear cell renal cell carcinoma; papillary renal cell carcinoma

Outcome Measures

Primary Outcomes (5)

• Overall response rate

  Up to 5 years

• Overall survival

  Up to 5 years

• Disease-free survival

  Up to 5 years

• Treatment-related mortality

  Up to 5 years

• Percentage of donor chimerism in patients treated

  Up to 5 years

Study Arms (1)

Chemotherapy + stem cell transplantation

EXPERIMENTAL

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 persistent disease and no signs of active GVHD may receive donor lymphocyte infusion (DLI). DLI may be repeated every 8 weeks for a total of 2 infusions. Patients are followed every 2 months for 1 year and then every 6 months for 4 years OR every 2 months for 6 months and then every 6 months for 4.5 years if patient receives DLI.

Biological: filgrastim; Biological: therapeutic allogeneic lymphocytes; Drug: cyclophosphamide; Drug: fludarabine phosphate; Drug: methotrexate; Drug: tacrolimus; Procedure: peripheral blood stem cell transplantation

Interventions

filgrastim BIOLOGICAL

Chemotherapy + stem cell transplantation

therapeutic allogeneic lymphocytes BIOLOGICAL

Chemotherapy + stem cell transplantation

cyclophosphamide DRUG

Chemotherapy + stem cell transplantation

fludarabine phosphate DRUG

Chemotherapy + stem cell transplantation

methotrexate DRUG

Chemotherapy + stem cell transplantation

tacrolimus DRUG

Chemotherapy + stem cell transplantation

peripheral blood stem cell transplantation PROCEDURE

Chemotherapy + stem cell transplantation

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

CCOP - Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

Related Publications (1)

• 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. doi: 10.1016/j.bbmt.2006.03.011.

  PMID: 16785067 RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Filgrastim; Cyclophosphamide; fludarabine phosphate; Methotrexate; Tacrolimus; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Lactones; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Brian I. Rini, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2001
• First Posted: January 27, 2003
• Study Start: October 1, 2001
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

US (6)