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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003269
Recruitment Status : Completed
First Posted : May 24, 2004
Last Update Posted : January 10, 2011
Information provided by:
Scripps Health

November 1, 1999
May 24, 2004
January 10, 2011
February 1998
January 2001   (Final data collection date for primary outcome measure)
duration of neutropenia [ Time Frame: 30 days ]
number of days absolute neutrophil count less than 500 during the nadir period after administration of high dose chemotherapy
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Complete list of historical versions of study NCT00003269 on Archive Site
  • incidence of nephrotoxicity [ Time Frame: 30 days ]
    decrease in creatinine clearance from baseline after high dose chemotherapy
  • incidence of ototoxicity [ Time Frame: 30 days ]
    change in audiogram from baseline after high dose chemotherapy
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Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
A Phase II, Open-Label, Trial Evaluating the Efficacy of Amifostine in Patients With Cancers Receiving Outpatient Dose-intensive Cyclophosphamide, Etoposide, and Cisplatin (DICEP) Chemotherapy

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.

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.

Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Breast Cancer
  • Drug/Agent Toxicity by Tissue/Organ
  • Lung Cancer
  • Lymphoma
  • Ovarian Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Biological: sargramostim
  • Drug: amifostine trihydrate
  • Drug: cisplatin
  • Drug: cyclophosphamide
  • Drug: etoposide
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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January 2001
January 2001   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically confirmed hematologic malignancies and adult solid tumors, including: Non-Hodgkin's lymphoma Lung cancer Hodgkin's disease Ovarian cancer Breast cancer No refractory disease (less than partial response to induction chemotherapy) No CNS metastases No unilateral bone marrow biopsy within 6 months of study showing at least 20% involvement by fibrosis tumors Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 to 70 Menopausal status: Not specified Performance Status: ECOG 0-2 Life expectancy: At least 16 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT or SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Other: HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No underlying medical or psychiatric conditions No concurrent active infection No prior malignancies except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior myeloid growth factor Chemotherapy: At least 4 weeks since prior chemotherapy No more than 1 prior chemotherapy regimen (excluding adjuvant chemotherapy) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since pelvic, para-aortic, inverted Y, cranial, spinal, or mediastinal radiation Surgery: At least 2 weeks since major surgery Other: No antihypertensive medication within 24 hours of amifostine administration

Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
SCRF-98014 ( Other Identifier: Scripps Health )
ALZA-97-49-ii ( Other Identifier: Alza Corporation )
NCI-V98-1396 ( Other Identifier: NCI )
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James R. Mason, M.D., Scripps Health
Scripps Health
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Study Chair: James R. Mason, MD Ida M. and Cecil H. Green Cancer Center at Scripps Clinic
Scripps Health
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP