Clinical trial NCT00042900: Pyroxamide in Treating Patients With Advanced Cancer
Official title: A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Precancerous Condition
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: 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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-07-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Leonard B. Saltz, MD
role: STUDY_CHAIR
References: