Non Hodgkin Lymphoma Clinical Trial

Clinical Trial Finder Non Hodgkin Lymphoma Trials

Decitabine With or Without Valproic Acid in Treating Patients With Relapsed or Refractory Non-Hodgkin’s Lymphoma

See Locations Near You

Summary

Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Valproic acid may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine together with valproic acid may be an effective treatment for non-Hodgkin's lymphoma. This phase I trial is studying the side effects and best dose of decitabine and valproic acid in treating patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma.

View Full Description

Full Description

PRIMARY OBJECTIVES:

I. Determine the minimally effective pharmacological dose (MEPD) of single-agent decitabine in patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma.

II. Determine the maximum tolerated dose of valproic acid when administered with the MEPD of decitabine in these patients.

III. Determine the MEPD of valproic acid when administered with decitabine in these patients.

IV. Determine the toxic effects of decitabine alone and in combination with valproic acid in these patients.

SECONDARY OBJECTIVES:

I. Determine the response rate in patients treated with these drugs. II. Determine the pharmacokinetics of these drugs in these patients.

OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 treatment stages.

STAGE 1: Patients receive decitabine IV over 1 hour on days 1-5 or 1-10. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

STAGE 2: Patients receive decitabine as in stage 1 and valproic acid orally (PO) thrice daily (TID) on days 5-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

For both stages, patients who achieve an objective response (complete response [CR], unconfirmed CR, or partial response) may discontinue study treatment and undergo stem cell transplantation, if eligible.

PROJECTED ACCRUAL: Approximately 18-42 patients (18 for stage 1 and 24 for stage 2) will be accrued for this study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed aggressive B-cell non-Hodgkin's lymphoma (NHL), including any of the following subtypes:

Mantle cell lymphoma
Diffuse large cell lymphoma
Burkitt's lymphoma

Transformed NHL* arising from a previously diagnosed low-grade lymphoma, including any of the following:

Follicular lymphoma
Small lymphocytic lymphoma
Chronic lymphocytic leukemia

Relapsed or refractory disease

Relapsed or refractory disease must have occurred during the most recent prior therapy
Has accessible tissue for biopsy OR evidence of ≥ 50% bone marrow involvement AND willing to undergo serial biopsy
Not eligible for OR refused curative stem cell transplantation
No active or untreated CNS lymphoma
Performance status - ECOG 0-2
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 75,000/mm^3
AST and ALT ≤ 2.5 times upper limit of normal
Bilirubin ≤ 1.5 mg/dL
Creatinine ≤ 2.0 mg/dL
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No known HIV positivity
No ongoing or active infection
No other uncontrolled illness
No psychiatric illness or social situation that would preclude study compliance
Prior stem cell transplantation allowed
Recovered from all prior biologic therapy-related toxicity
Recovered from all prior chemotherapy-related toxicity
No other concurrent chemotherapy unless it is used in the chronic daily setting for other medical conditions, including pulmonary, rheumatologic, or adrenal disorders
No concurrent corticosteroids unless they are used in the chronic daily setting for other medical conditions, including pulmonary, rheumatologic, or adrenal disorders
Recovered from all prior radiotherapy-related toxicity
No concurrent palliative radiotherapy
Recovered from all prior therapy-related toxicity
No concurrent anticonvulsants, including valproic acid (except as used in this study)

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

42

Study ID:

NCT00109824

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Ohio State University Medical Center
Columbus Ohio, 43210, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

42

Study ID:

NCT00109824

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

Clinical Trial Resources

Why I’d Choose a Clinical Trial For Myself
Clinical Trials Can be Life-Saving for Some
Clinical Trials Test State-of-the-Art Cancer Treatments
×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider