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Home > "P" Clinical Trials Conditions > Pyroxamide in Treating Patients With Advanced Cancer Pyroxamide in Treating Patients With Advanced Cancer
Pyroxamide in Treating Patients With Advanced Cancer
For Condition: Eye Cancer,Lymphoma,Leukemia,Multiple Myeloma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of pyroxamide in treating patients who have advanced cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of pyroxamide in patients with advanced malignancies. II. Define, qualitatively and quantitatively, the dose-limiting and non-dose-limiting toxic effects of this drug in these patients. III. Describe the pharmacologic behavior of this drug in these patients. PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive pyroxamide IV continuously over 5-7 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of pyroxamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed monthly for resolution of adverse events. PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically or cytologically confirmed solid tumor or hematologic malignancy - Disease that has failed standard therapies (e.g., surgery, radiotherapy, endocrine therapy, or chemotherapy) or for which no curative or life- prolonging therapy is available Measurable or clinically evaluable disease - Elevated tumor marker is acceptable for evaluable disease No known carcinomatous meningitis, primary brain tumors, or metastatic brain disease --Prior/Concurrent Therapy-- Biologic therapy: No concurrent bone marrow growth factors Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: - See Disease Characteristics Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior wide-field radiotherapy and recovered - At least 2 weeks since prior limited-field radiotherapy and recovered - Recovered from prior radiotherapy Surgery: See Disease Characteristics Other: No other concurrent antitumor treatment --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 125,000/mm3 - Hemoglobin at least 9.0 g/dL Hepatic: - Bilirubin normal - AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present) - PT no greater than 1.5 times ULN Renal: Creatinine normal Other: - HIV-positive status allowed - Prior malignancy allowed - No severe physical or emotional illness that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeonardSaltz, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000069483; NCI-2110,MSKCC-99090
Study Start Date: April 2002
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042900
Other Multiple Myeloma Studies:
1. Epoetin alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy
2. Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon
3. UARK 2003-33, Total Therapy III
4. Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
5. Bone Marrow Transplant Studies for Safe and Effective Treatment of Leukemia
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Pyroxamide in Treating Patients With Advanced Cancer
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