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Related Studies
Pyroxamide in Treating Patients With Advanced Cancer
This study has been completed.
First Received: August 5, 2002   Last Updated: November 16, 2008   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00042900
  Purpose

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.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Precancerous/Nonmalignant Condition
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: pyroxamide
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies

Resource links provided by NLM:


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

Study Start Date: April 2002
Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042900

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Leonard B. Saltz, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069483, MSKCC-99090, NCI-2110
Study First Received: August 5, 2002
Last Updated: November 16, 2008
ClinicalTrials.gov Identifier: NCT00042900     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma
T-cell large granular lymphocyte leukemia
Waldenstrom macroglobulinemia
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
chronic idiopathic myelofibrosis
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
blastic phase chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
essential thrombocythemia
extramedullary plasmacytoma
intraocular lymphoma
isolated plasmacytoma of bone
meningeal chronic myelogenous leukemia
monoclonal gammopathy of undetermined significance
polycythemia vera
previously treated myelodysplastic syndromes
primary central nervous system lymphoma
primary systemic amyloidosis
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
recurrent adult Hodgkin lymphoma
recurrent adult T-cell leukemia/lymphoma
recurrent adult acute lymphoblastic leukemia

Study placed in the following topic categories:
Blast Crisis
Mantle Cell Lymphoma
Ileal Diseases
Preleukemia
Leukemia, Prolymphocytic
Hemorrhagic Disorders
Lymphoma, Large-Cell, Anaplastic
Neoplasm Metastasis
Thrombocythemia, Hemorrhagic
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Blood Coagulation Disorders
Leukemia, Myeloid
Waldenstrom Macroglobulinemia
Plasmacytoma
Leukemia, Myeloid, Accelerated Phase
Chronic Myelogenous Leukemia
Lymphoma, Non-Hodgkin
Precancerous Conditions
Blood Protein Disorders
Lymphoma, Follicular
Sezary Syndrome
Lymphoblastic Lymphoma
Lymphoma, B-Cell
Leukemia
Ileal Neoplasms
Cutaneous T-cell Lymphoma
Lymphoma, T-Cell
Duodenal Diseases

Additional relevant MeSH terms:
Precancerous Conditions
Gastrointestinal Diseases
Blood Protein Disorders
Paraproteinemias
Hemostatic Disorders
Ileal Diseases
Duodenal Neoplasms
Leukemia
Preleukemia
Neoplasms by Site
Pathologic Processes
Hemorrhagic Disorders
Ileal Neoplasms
Jejunal Diseases
Syndrome
Cardiovascular Diseases
Lymphoma
Duodenal Diseases
Jejunal Neoplasms
Digestive System Neoplasms
Disease
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Vascular Diseases
Intestinal Diseases
Intestinal Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009