Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

azacitidine

sodium phenylbutyrate

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent non-small cell lung cancer, refractory multiple myeloma, recurrent adult acute myeloid leukemia, recurrent prostate cancer, adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute promyelocytic leukemia (M3), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, adult acute monocytic leukemia (M5b), previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of one of the following neoplastic diseases: Acute myeloid leukemia Myelodysplasia Low or intermediate grade non-Hodgkin's lymphoma Multiple myeloma Non-small cell lung cancer Prostate cancer Failed prior conventional therapy and no other known curative therapy exists Patients with non-Hodgkin's lymphoma, non-small cell lung cancer, and prostate cancer must have tumor cells in bone marrow or malignant effusions that are accessible for bone marrow aspiration or paracentesis/thoracentesis NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Patients without leukemia or myeloma: WBC at least 2,500/mm^3 Platelet count at least 75,000/mm^3 Hepatic: Bilirubin no greater than 2.5 mg/dL Renal: Creatinine no greater than 2.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 4 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Patients without leukemia: At least 3 weeks since prior cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: Patients without leukemia: At least 3 weeks since prior radiotherapy Surgery: Not specified

Sites / Locations

Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00006019

First Posted

July 5, 2000

Last Updated

June 20, 2013

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00006019

Brief Title

Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer

Official Title

Pilot Study of Sodium Phenylbutyrate Plus Azacytidine

Study Type

Interventional

2. Study Status

Record Verification Date

October 2002

Overall Recruitment Status

Completed

Study Start Date

May 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of phenylbutyrate plus azacitidine in treating patients who have acute myeloid leukemia, myelodysplasia, non-Hodgkin's lymphoma, multiple myeloma, non-small cell lung cancer, or prostate cancer.

Detailed Description

OBJECTIVES: Determine the ability of azacytidine in vivo to demethylate selected genes known to be transcriptionally repressed in patients with acute myeloid leukemia, myelodysplasia, non-Hodgkin's lymphoma, multiple myeloma, non-small cell lung cancer, or prostate cancer. Determine the ability of phenylbutyrate plus azacytidine to induce transcription of target genes that are known to be repressed as a consequence of DNA methylation in these patients. Determine the effect of this treatment regimen upon gene methylation and histone acetylation in target cells in these patients. Determine the technical feasibility of serially monitoring transcriptional activity and methylation status of selected genes in vivo in these patients. Determine the safety and potential antitumor efficacy of this treatment regimen in these patients. OUTLINE: Patients receive azacytidine subcutaneously on days 1-7 and phenylbutyrate IV over 1-2 hours on days 8-12. Patients with acute myeloid leukemia who respond to therapy may receive a second course approximately 10 days after the end of the first. Subsequent courses in these patients, and all additional courses in all other patients, are repeated every 21 to 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Lung Cancer, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Prostate Cancer

Keywords

recurrent non-small cell lung cancer, refractory multiple myeloma, recurrent adult acute myeloid leukemia, recurrent prostate cancer, adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute promyelocytic leukemia (M3), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, adult acute monocytic leukemia (M5b), previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

azacitidine

Intervention Type

Drug

Intervention Name(s)

sodium phenylbutyrate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Diagnosis of one of the following neoplastic diseases: Acute myeloid leukemia Myelodysplasia Low or intermediate grade non-Hodgkin's lymphoma Multiple myeloma Non-small cell lung cancer Prostate cancer Failed prior conventional therapy and no other known curative therapy exists Patients with non-Hodgkin's lymphoma, non-small cell lung cancer, and prostate cancer must have tumor cells in bone marrow or malignant effusions that are accessible for bone marrow aspiration or paracentesis/thoracentesis NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Patients without leukemia or myeloma: WBC at least 2,500/mm^3 Platelet count at least 75,000/mm^3 Hepatic: Bilirubin no greater than 2.5 mg/dL Renal: Creatinine no greater than 2.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 4 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Patients without leukemia: At least 3 weeks since prior cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: Patients without leukemia: At least 3 weeks since prior radiotherapy Surgery: Not specified

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Maslak, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Leukemia, Lung Cancer, Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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