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

This study has been completed.
Sponsor:
Information provided by:
Scripps Health
ClinicalTrials.gov Identifier:
NCT00003269
First received: November 1, 1999
Last updated: January 6, 2011
Last verified: January 2011
  Purpose

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
Lymphoma
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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    decrease in creatinine clearance from baseline after high dose chemotherapy

  • incidence of ototoxicity [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00003269

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

Additional Information:
No publications provided

Responsible Party: James R. Mason, M.D., Scripps Health
ClinicalTrials.gov Identifier: NCT00003269     History of Changes
Other Study ID Numbers: CDR0000066165, SCRF-98014, ALZA-97-49-ii, NCI-V98-1396
Study First Received: November 1, 1999
Last Updated: January 6, 2011
Health Authority: United States: Food and Drug Administration

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:
Breast Neoplasms
Lung Neoplasms
Lymphoma
Lymphoma, Non-Hodgkin
Ovarian Neoplasms
Lymphoma, Large-Cell, Immunoblastic
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Etoposide phosphate
Cisplatin
Cyclophosphamide

ClinicalTrials.gov processed this record on August 20, 2014