Pyroxamide in Treating Patients With Ad… | Clinical Trial

Key information

Conditions

Chronic Myeloproliferative Disorders Amyloidosis Blast Crisis Blood Coagulation Disorders Blood Platelet Disorders Blood Protein Disorders Bone Marrow Diseases Bone Marrow Neoplasms Burkitt Lymphoma Carcinogenesis Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease DNA Virus Infections Disease Attributes Epstein-Barr Virus Infections Eye Neoplasms Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Hypergammaglobulinemia Immune System Diseases Immunoblastic Lymphadenopathy Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Infections Intraocular Lymphoma Leukemia Leukemia, B-Cell Leukemia, Biphenotypic, Acute Leukemia, Hairy Cell Leukemia, Large Granular Lymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Prolymphocytic Leukemia, T-Cell Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Metabolic Diseases Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Multiple Myeloma and Plasma Cell Neoplasm Mycosis Fungoides Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Neoplastic Processes Nutritional and Metabolic Diseases Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Polycythemia Vera Precancerous Condition Precancerous Conditions Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis Proteostasis Deficiencies Sezary Syndrome Small Intestine Cancer Thrombocythemia, Essential Thrombocytosis Tumor Virus Infections Unspecified Adult Solid Tumor, Protocol Specific Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10021, United States

About this study

OBJECTIVES:

Determine the maximum tolerated dose of pyroxamide in patients with advanced malignancies.
Define, qualitatively and quantitatively, the dose-limiting and non-dose-limiting toxic effects of this drug in these patients.
Describe the pharmacologic behavior of this drug in these patients.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 125,000/mm^3
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 participation
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

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

Treatment and study plan

pyroxamide

Drug

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies

Important dates

Study start: 2002
Primary completion: 2002
Study completion: 2002
First posted: Jul 8, 2003
Registry last updated: Jun 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed