Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by:
Scripps Health Identifier:
First received: November 1, 1999
Last updated: January 6, 2011
Last verified: January 2011

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.

Condition Intervention Phase
Breast Cancer
Drug/Agent Toxicity by Tissue/Organ
Lung Cancer
Ovarian Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Biological: sargramostim
Drug: amifostine trihydrate
Drug: cisplatin
Drug: cyclophosphamide
Drug: etoposide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Scripps Health:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Enrollment: 20
Study Start Date: February 1998
Study Completion Date: January 2001
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003269

United States, California
Scripps Clinic
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Health
Study Chair: James R. Mason, MD Ida M. and Cecil H. Green Cancer Center at Scripps Clinic
  More Information

Responsible Party: James R. Mason, M.D., Scripps Health Identifier: NCT00003269     History of Changes
Other Study ID Numbers: CDR0000066165
SCRF-98014 ( Other Identifier: Scripps Health )
ALZA-97-49-ii ( Other Identifier: Alza Corporation )
NCI-V98-1396 ( Other Identifier: NCI )
Study First Received: November 1, 1999
Last Updated: January 6, 2011

Keywords provided by Scripps Health:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
stage I breast cancer
stage II breast cancer
stage IV breast cancer
stage IIIA breast cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIB breast cancer
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
Waldenstrom macroglobulinemia
limited stage small cell lung cancer
extensive stage small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
unspecified adult solid tumor, protocol specific
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage I adult diffuse small cleaved cell lymphoma

Additional relevant MeSH terms:
Lung Neoplasms
Breast Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Breast Diseases
Skin Diseases
Etoposide phosphate
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists processed this record on April 21, 2017