Pyroxamide in Treating Patients With Advanced Cancer
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ClinicalTrials.gov Identifier: NCT00042900 |
Recruitment Status
:
Completed
First Posted
: July 8, 2003
Last Update Posted
: June 5, 2013
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous Condition Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific | Drug: pyroxamide | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies |
Study Start Date : | April 2002 |
Actual Primary Completion Date : | September 2002 |
Actual Study Completion Date : | September 2002 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042900
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Leonard B. Saltz, MD | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00042900 History of Changes |
Other Study ID Numbers: |
99-090 CDR0000069483 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-2110 |
First Posted: | July 8, 2003 Key Record Dates |
Last Update Posted: | June 5, 2013 |
Last Verified: | June 2013 |
Keywords provided by Memorial Sloan Kettering Cancer Center:
AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma T-cell large granular lymphocyte leukemia Waldenström macroglobulinemia accelerated phase chronic myelogenous leukemia acute undifferentiated leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission primary 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 non-Hodgkin 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 |
Additional relevant MeSH terms:
Lymphoma Syndrome Leukemia Multiple Myeloma Neoplasms, Plasma Cell Myelodysplastic Syndromes Preleukemia Plasmacytoma Myeloproliferative Disorders Precancerous Conditions Intestinal Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Disease Pathologic Processes Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |