Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors

Phase 2

Completed

• Conditions: Breast Cancer; Drug/Agent Toxicity by Tissue/Organ; Lung Cancer; Lymphoma; Ovarian Cancer; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00003269
• Lead Sponsor: Scripps Health

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.

PURPOSE: Randomized phase II trial to study the effectiveness of amifostine followed by high-dose chemotherapy in treating patients with hematologic cancer or solid tumors.

Detailed Description

OBJECTIVES: I. Evaluate the efficacy of amifostine in enhancing hematopoietic recovery following cyclophosphamide, etoposide, and cisplatin therapy in patients with hematologic malignancies and adult solid tumors.

OUTLINE: This is an open label study. Patients receive intravenous amifostine over 15 minutes daily 30 minutes prior to high dose chemotherapy on days 0-2. Cyclophosphamide is administered over 3 hours on days 0 and 1, intravenous etoposide over 4 hours on days 0, 1, and 2, and cisplatin over 4 hours on days 0, 1, and 2. All patients receive sargramostim (GM-CSF) beginning on day 4. Patients receive a maximum of 2 courses of treatment (with 35-42 days between chemotherapy courses). Patients are followed for 1-5 months after treatment.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 12 months.

Study Timeline

• Study Start: 1998-02
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-01
• Study Completion: 2001-01
• Study First Submitted QC: 2004-05-21
• Study First Posted: 2004-05-24
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-06
• Last Update Posted: 2011-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
duration of neutropenia	30 days	number of days absolute neutrophil count less than 500 during the nadir period after administration of high dose chemotherapy

Secondary Outcome Measures

Name	Time	Method
incidence of nephrotoxicity	30 days	decrease in creatinine clearance from baseline after high dose chemotherapy
incidence of ototoxicity	30 days	change in audiogram from baseline after high dose chemotherapy

Trial Locations

Locations (1)

Scripps Clinic; 🇺🇸 La Jolla, California, United States