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A Phase II Trial of Flavopiridol (NSC 649890) Administered as a 72-Hour Continuous Infusion Every 2 Weeks in Patients With Previously Treated Intermediate and High Grade Non-Hodgkin's Lymphoma Including Mantle Cell Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase II Trial of Flavopiridol (NSC 649890) Administered as a 72-Hour Continuous Infusion Every 2 Weeks in Patients With Previously Treated Intermediate and High Grade Non-Hodgkin's Lymphoma Including Mantle Cell Lymphoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Todd M. Zimmerman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02253

NCT ID:

NCT00003039

Start Date:

September 1997

Completion Date:

Related Keywords:

  • 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
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Mantle-Cell

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Evanston Northwestern Health CareEvanston, Illinois  60201
Lutheran General HospitalPark Ridge, Illinois  60068
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
Clinical Sciences BuildingChicago, Illinois  60612
Cancer Care Specialists of Central Illinois, S.C.Decatur, Illinois  62526
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Central Illinois Hematology Oncology CenterSpringfield, Illinois  62701
Fort Wayne Medical Oncology and Hematology, Inc.Fort Wayne, Indiana  46885-5099
Michiana Hematology/Oncology P.C.South Bend, Indiana  46617