Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Metastatic Kidney Cancer

NCT00004135 | Completed Phase 2

• 4 other identifiers: 9672UCCRC-9672UCCRC-CTRC-9866NCI-G99-1612
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 plus peripheral stem cell transplantation in treating patients who have metastatic kidney cancer or melanoma.

Conditions

Kidney Cancer; Melanoma (Skin)

Keywords

stage IV renal cell cancer; recurrent renal cell cancer; stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  3 years

Study Arms (1)

Arm A

EXPERIMENTAL

Fludarabine 30 mg/m2/d x S days IVPB in 100 cc NS over 30 minutes on day -8, -7, -6, -S, and -4. Cyclophosphamide 2 gm/m2/d x 2 days IVPB in SOO cc DS W over I hour on day -3 and day-2. G-CSF (Neupogen®) administration 480 f!gld subcutaneously starting on day +5 (or first day of neutropenia if earlier)and continued until an ANC of 0.5 x 109/L is maintained for 3 consecutive days.

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

Interventions

filgrastim BIOLOGICAL

Arm A

therapeutic allogeneic lymphocytes BIOLOGICAL

Arm A

cyclophosphamide DRUG

Arm A

fludarabine phosphate DRUG

Arm A

peripheral blood stem cell transplantation PROCEDURE

Arm A

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic renal cell carcinoma or melanoma that is not potentially curable by surgery * Evaluable disease or bidimensionally measurable disease on physical examination, chest x-ray, CT scan, or MRI * Measurable disease by radiography must be reproducible * Bony disease or effusions not measurable * No active CNS disease currently receiving radiotherapy or steroids * No effusion or ascites of more than 1 liter prior to drainage * HLA 5/6 or 6/6 matched sibling donor available * No known hypersensitivity to E. coli derived products * No active infection * No health condition that would preclude donation PATIENT CHARACTERISTICS: Age: * 18 to 65 Performance status: * CALGB 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2.0 g/dL * No active hepatitis Renal: * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance greater than 50 mL/min Cardiovascular: * LVEF at least 50% Pulmonary: * DLCO at least 50% of predicted Other: * No active infection * HIV negative * No psychological problem that would preclude study compliance * No known hypersensitivity to E. coli derived products * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior systemic chemotherapy Endocrine therapy: * See Disease Characteristics Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics

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

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Melanoma; Carcinoma, Renal Cell

Interventions

Filgrastim; Cyclophosphamide; fludarabine phosphate; 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; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

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; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Todd M. Zimmerman, MD

  University of Chicago

  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 10, 1999
• First Posted: January 27, 2003
• Study Start: February 1, 1999
• Primary Completion: October 1, 2004
• Study Completion: August 1, 2007
• Last Updated: March 7, 2014

Record last verified: 2014-03

Locations

US (1)