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

Primary Purpose

Breast Cancer, Drug/Agent Toxicity by Tissue/Organ, Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sargramostim
amifostine trihydrate
cisplatin
cyclophosphamide
etoposide
Sponsored by
Scripps Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring 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, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage I adult lymphoblastic lymphoma, stage I adult Burkitt lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III adult Burkitt lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult Burkitt lymphoma, stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, drug/agent toxicity by tissue/organ, stage I mantle cell lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, contiguous stage II adult diffuse small cleaved cell lymphoma, contiguous stage II mantle cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult Burkitt lymphoma, contiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II mantle cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma, stage I marginal zone lymphoma, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage III marginal zone lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, contiguous stage II marginal zone lymphoma, contiguous stage II small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps Clinic

Outcomes

Primary Outcome Measures

duration of neutropenia
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
decrease in creatinine clearance from baseline after high dose chemotherapy
incidence of ototoxicity
change in audiogram from baseline after high dose chemotherapy

Full Information

First Posted
November 1, 1999
Last Updated
January 6, 2011
Sponsor
Scripps Health
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1. Study Identification

Unique Protocol Identification Number
NCT00003269
Brief Title
Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
February 1998 (undefined)
Primary Completion Date
January 2001 (Actual)
Study Completion Date
January 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Scripps Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Drug/Agent Toxicity by Tissue/Organ, Lung Cancer, Lymphoma, Ovarian Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
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, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage I adult lymphoblastic lymphoma, stage I adult Burkitt lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III adult Burkitt lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult Burkitt lymphoma, stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, drug/agent toxicity by tissue/organ, stage I mantle cell lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, contiguous stage II adult diffuse small cleaved cell lymphoma, contiguous stage II mantle cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult Burkitt lymphoma, contiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II mantle cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma, stage I marginal zone lymphoma, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage III marginal zone lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, contiguous stage II marginal zone lymphoma, contiguous stage II small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Drug
Intervention Name(s)
amifostine trihydrate
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
etoposide
Primary Outcome Measure Information:
Title
duration of neutropenia
Description
number of days absolute neutrophil count less than 500 during the nadir period after administration of high dose chemotherapy
Time Frame
30 days
Secondary Outcome Measure Information:
Title
incidence of nephrotoxicity
Description
decrease in creatinine clearance from baseline after high dose chemotherapy
Time Frame
30 days
Title
incidence of ototoxicity
Description
change in audiogram from baseline after high dose chemotherapy
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James R. Mason, MD
Organizational Affiliation
Ida M. and Cecil H. Green Cancer Center at Scripps Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

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

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