A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Precancerous Condition, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Precancerous Condition, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Leonard B. Saltz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
99-090
NCT ID:
NCT00042900
Start Date:
April 2002
Completion Date:
September 2002
Related Keywords:
- Chronic Myeloproliferative Disorders
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Precancerous Condition
- Small Intestine Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
- 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
- recurrent adult acute myeloid leukemia
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult Burkitt lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent mantle cell lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- refractory chronic lymphocytic leukemia
- refractory hairy cell leukemia
- refractory multiple myeloma
- relapsing chronic myelogenous leukemia
- secondary acute myeloid leukemia
- secondary myelodysplastic syndromes
- small intestine lymphoma
- stage III adult Hodgkin lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult Burkitt lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III chronic lymphocytic leukemia
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III multiple myeloma
- stage III mycosis fungoides/Sezary syndrome
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult Burkitt lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV chronic lymphocytic leukemia
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV mantle cell lymphoma
- stage IV mycosis fungoides/Sezary syndrome
- untreated adult acute lymphoblastic leukemia
- untreated adult acute myeloid leukemia
- untreated hairy cell leukemia
- stage IV adult Hodgkin lymphoma
- stage IV adult T-cell leukemia/lymphoma
- unspecified adult solid tumor, protocol specific
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- Neoplasms
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Precancerous Conditions
- Lymphoma, Large-Cell, Immunoblastic
- Duodenal Neoplasms
- Ileal Neoplasms
- Jejunal Neoplasms
- Intestinal Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
