Flavopiridol in Treating Patients With Recurrent Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: alvocidib

Study type: Interventional

Funder types: NIH

Identifiers

NCT00003039

NCI-2012-02253

NCI-T96-0099

CDR0000065663 (Registry Identifier)

UCCRC-8548

Details and patient eligibility

About

Phase II trial to study the effectiveness of flavopiridol in treating patients with recurrent intermediate-grade or high-grade non-Hodgkin's lymphoma or mantle cell lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

Full description

OBJECTIVES:

I. Determine the objective response rate to flavopiridol by patients with previously treated intermediate and high grade non-Hodgkin's lymphoma and mantle cell lymphoma.

II. Determine the toxicity of flavopiridol administered as a continuous infusion every 2 weeks in these patients.

III. Study the pharmacokinetics of flavopiridol in these patients.

OUTLINE: This is an open label, multi-institutional study.

Patients receive treatment on an outpatient basis. Flavopiridol is administered as a continuous infusion over 72 hours every 2 weeks. Patients receive a minimum of 4 cycles of therapy unless unacceptable toxicity or disease progression occurs. Patients are followed until death.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed intermediate or high grade non-Hodgkin's lymphoma (NHL) and mantle cell lymphoma with clinical or pathological evidence of recurrent disease
• Measurable or evaluable disease
• CNS metastases not requiring intravenous steroid therapy allowed

PATIENT CHARACTERISTICS:

• Age: 18 and over
• Performance status: CALGB 0-2
• Life expectancy: At least 12 weeks
• Absolute neutrophil count at least 1500/mm3 (unless due to bone marrow involvement by lymphoma)
• Platelet count at least 100,000/mm3 (unless due to bone marrow involvement by lymphoma)
• At least 7 days since platelet transfusion
• Hemoglobin at least 9.0 g/dL
• Bilirubin no greater than 1.5 mg/dL
• Transaminases no greater than 2.5 times upper limit of normal
• Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min
• No significant uncontrolled medical or psychiatric illness
• No active serious infection
• Not pregnant or lactating
• Fertile patients must use effective contraception
• Central venous catheter required prior to study entry

PRIOR CONCURRENT THERAPY:

• No more than 1 prior chemotherapy regimen
• At least 4 weeks since prior chemotherapy and recovered from all toxic effects Prior chemotherapy must contain anthracycline if intermediate or high-grade NHL other than mantle cell
• No concurrent treatment with other chemotherapeutic or investigational antineoplastic drugs
• At least 4 weeks since prior radiation therapy and recovered (Site of only measurable disease must not be located within prior radiation therapy port)
• No concurrent radiation therapy to any lesion

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Arm I

Experimental group

Description:

Patients receive treatment on an outpatient basis. Flavopiridol is administered as a continuous infusion over 72 hours every 2 weeks. Patients receive a minimum of 4 cycles of therapy unless unacceptable toxicity or disease progression occurs.

Treatment:

Drug: alvocidib