Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Recurrent Kidney Cancer

NCT00025519 | Withdrawn Phase 2

• 4 other identifiers: FCCC-01006CDR0000068970TUHSC-3721NCI-G01-2021
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. Sometimes the transplanted cells can be rejected by the body's tissues. Mycophenolate mofetil, tacrolimus, and donor white blood cells may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have metastatic or recurrent kidney cancer.

Conditions

Kidney Cancer

Keywords

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

Interventions

therapeutic allogeneic lymphocytes BIOLOGICAL

fludarabine phosphate DRUG

mycophenolate mofetil DRUG

tacrolimus DRUG

thalidomide DRUG

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma (RCC) * Histology demonstrates major clear cell component * Metastatic (stage IV) or recurrent disease * Prior debulking nephrectomy required * Disease not amenable to complete surgical resection * Must have HLA-identical donor * Matched related sibling donors must have 6/6 serologic HLA A, B, and DR match with molecular confirmation at DRB1 * A 5/6 serologic mismatch with one antigen mismatch at locus A or B (not DR) with molecular confirmation at locus A, B, and DRB1 allowed * Matched unrelated donors must have a minimum of 8 out of 10 molecular matches at loci A, B, C, DRB1, and DQB1 * No brain metastases * Negative MRI required PATIENT CHARACTERISTICS: Age: * 18 to 65 Performance status: * Karnofsky 80-100% OR * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 2 times upper limit of normal (ULN) * ALT/AST less than 2 times ULN * Alkaline phosphatase less than 2 times ULN * Hepatitis A, B, and C negative Renal: * Creatinine clearance greater than 50 mL/min * Calcium less than 10.5 mg/dL (bisphosphonates allowed) Cardiovascular: * LVEF no less than 10% below lower limit of normal Pulmonary: * FEV\_1 and DLCO greater than 50% Other: * HIV negative * No active bacterial, fungal, or viral (including cytomegalovirus) infections * No intolerance or allergy to tacrolimus, mycophenolate mofetil, or fludarabine * No intolerance to 200 cGy of total body irradiation * No other serious comorbid disease, neurologic condition, or psychosocial condition that would preclude study follow-up * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for at least 1 month before, during, and for at least 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior interleukin-2 allowed * Prior interferon alfa allowed Chemotherapy: * Prior chemotherapy allowed * No other concurrent chemotherapy for RCC Endocrine therapy: * No concurrent corticosteroids for other comorbid disease Radiotherapy: * No prior extensive radiotherapy to marrow microenvironment greater than 20% of total marrow mass * No prior radiotherapy that has reached tissue tolerance for heart, lung, liver, kidney, or spinal cord Surgery: * See Disease Characteristics Other: * No other concurrent therapy for RCC * No concurrent enrollment on another investigational protocol for treatment of RCC * No other concurrent immunosuppressive medications * No other concurrent investigational drugs

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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

fludarabine phosphate; Mycophenolic Acid; Tacrolimus; Thalidomide; Peripheral Blood Stem Cell Transplantation; Radiotherapy

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)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Macrolides; Lactones; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Gary R. Hudes, MD

  Fox Chase Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: June 1, 2001
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: July 11, 2013

Record last verified: 2013-07