Combination Chemotherapy Plus Amifostine in Treating Patients With Advanced Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004036
First received: December 10, 1999
Last updated: December 18, 2013
Last verified: May 2007
  Purpose

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

PURPOSE: Phase I trial to study the effectiveness of amifostine plus combination chemotherapy in treating patients with advanced cancer.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Drug/Agent Toxicity by Tissue/Organ
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Precancerous Condition
Unspecified Adult Solid Tumor, Protocol Specific
Biological: sargramostim
Drug: amifostine trihydrate
Drug: carboplatin
Drug: cyclophosphamide
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: Phase I Trial of High Dose Chemotherapy Using Amifostine for In-Vivo Protection of GM-CSF Primed Progenitor Cells

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Leukemia, Myeloid Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Polycythemia Vera Multiple Myeloma Acute Myeloid Leukemia, Adult Lymphoma, Small Cleaved-cell, Diffuse Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Acute Lymphoblastic Leukemia Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Follicular Lymphoma Lymphoma, Large-cell Myelodysplastic Syndromes Leukemia, T-cell, Chronic Lymphoblastic Lymphoma B-cell Lymphomas Burkitt Lymphoma Lymphoma, Large-cell, Immunoblastic Plasmablastic Lymphoma Hodgkin Lymphoma Mantle Cell Lymphoma Waldenstrom Macroglobulinemia Anaplastic Large Cell Lymphoma Chronic Myeloproliferative Disorders Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Large Granular Lymphocyte Leukemia Lymphosarcoma Essential Thrombocythemia Myelofibrosis Central Nervous System Lymphoma, Primary Hairy Cell Leukemia AL Amyloidosis Anaplastic Plasmacytoma Monoclonal Gammopathy of Undetermined Significance
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: November 1997
Detailed Description:

OBJECTIVES: I. Determine the effects of priming on the granulocyte and thrombocyte nadirs produced by high dose cyclophosphamide and carboplatin in patients with advanced malignancies. II. Determine the effects of amifostine on the granulocyte and thrombocyte nadirs produced by this same regimen when administered with sargramostim primed progenitor cells. III. Determine the maximum tolerated dose of cyclophosphamide and carboplatin that can be administered with sargramostim primed progenitor cells.

OUTLINE: This is a dose escalation study. Patients receive intravenous amifostine over 10 minutes on day 0, followed by intravenous cyclophosphamide and carboplatin consecutively over 5-15 minutes. Sargramostim is administered subcutaneously on days -7 to -2 and again beginning on day 1 until absolute neutrophil count is appropriate. Course is repeated every 28 days until disease progression or unacceptable toxic effects are observed. Nonresponding patients discontinue treatment after 2 courses. Patients are treated for a maximum of 6 courses. Groups of 3-6 patients receive escalating doses of cyclophosphamide and carboplatin until the maximum tolerated dose (MTD) is determined. If dose limiting toxicity (DLT) occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the MTD.

PROJECTED ACCRUAL: Approximately 24-30 patients will be accrued for this study within 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven advanced malignancies that are sensitive to cyclophosphamide/carboplatin therapy OR refractory to standard therapy, including, but not limited to: Ovarian epithelial cancer Colorectal cancer Breast cancer Sarcoma Non-small cell lung cancer Malignant melanoma Upper gastrointestinal cancers Small cell lung cancer

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 SWOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 8.5 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min OR Iothalamate clearance at least 60 mL/min Cardiovascular: No significant coronary artery disease (angina of New York Heart Association class 3 or greater) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No psychosis

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No more than 1 prior chemotherapy regimen for advanced or recurrent malignancies (not including adjuvant chemotherapy) No prior nitrosoureas or intravenous mitomycin No concurrent cytotoxic chemotherapy Endocrine therapy: At least 1 week since prior hormone therapy and recovered Concurrent corticosteroid therapy allowed Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Radiotherapy allowed to no more than 1 site in the thoracic or lumbar spine or pelvis Concurrent radiotherapy to a symptomatic lesion allowed after the first course of study treatment Surgery: At least 3 weeks since prior surgery and recovered (excluding recent biopsy or placement of an intravenous access device)

  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: NCT00004036

Locations
United States, Ohio
Cleveland Clinic Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Chair: George Thomas Budd, MD The Cleveland Clinic
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00004036     History of Changes
Other Study ID Numbers: CDR0000066347, CCF-IRB-1907, IMMUNEX-001.G9701, NCI-V98-1424
Study First Received: December 10, 1999
Last Updated: December 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
monoclonal gammopathy of undetermined significance
recurrent adult Hodgkin lymphoma
isolated plasmacytoma of bone
extramedullary plasmacytoma
refractory multiple myeloma
Waldenström macroglobulinemia
stage III multiple myeloma
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
unspecified adult solid tumor, protocol specific
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
polycythemia vera
primary myelofibrosis
essential thrombocythemia
untreated hairy cell leukemia
progressive hairy cell leukemia, initial treatment
refractory hairy cell leukemia

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Plasmacytoma
Myeloproliferative Disorders
Precancerous Conditions
Lymphoma
Leukemia
Syndrome
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Lymphatic Diseases
Disease
Pathologic Processes
Cyclophosphamide
Amifostine
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 22, 2014