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A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma


OBJECTIVES:

- Assess the efficacy of flavopiridol in terms of response rate in patients with
previously untreated or relapsed mantle cell lymphoma.

- Assess the toxicity of this regimen in this patient population.

- Determine the time to progression and, if responses are observed, response duration in
these patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive flavopiridol IV over 1 hour daily for 3 days. Treatment continues every 3
weeks in the absence of unacceptable toxicity or disease progression. Patients with a
complete response (CR) receive 2 additional courses after documented CR. Patients with a
partial response receive 2 additional courses after documented maximal tumor shrinkage.
Patients with stable disease receive a maximum of 4 courses.

Patients are followed at 4 weeks and then every 3 months until relapse or death.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 18-24
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed mantle cell lymphoma (at initial diagnosis)
nonrefractory to prior therapy or with no prior therapy

- No documented disease progression while receiving prior chemotherapy

- CD20 and CD5 positive

- Presence of clinically and/or radiologically documented disease

- At least 1 site of disease must be bidimensionally measurable

- Bone lesions not considered bidimensionally measurable

- Minimum indicator lesions must be:

- Lymph nodes at least 1.5 cm x 1.5 cm by physical exam or spiral CT scan OR

- Other nonnodal lesions at least 1 cm x 1 cm by MRI, CT scan, or physical
exam

- No known CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- Absolute granulocyte count at least 1,500/mm3

- Platelet count at least 75,000/mm3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit or normal (ULN)

- AST no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No clinically significant cardiac symptomatology

- If history of cardiac disease, cardiac ejection fraction greater than 50%

Pulmonary:

- No clinically significant pulmonary symptomatology

- If history of symptomatic pulmonary disease:

- FEV1, FVC, and TLC greater than 60% predicted

- DLCO greater than 50% predicted

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Must be accessible for treatment and follow-up (i.e., no geographical limitations)

- No uncontrolled bacterial, fungal, or viral infection

- No other serious concurrent disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior radioactive monoclonal antibody therapy

- Prior rituximab allowed

Chemotherapy:

- See Disease Characteristics

- No more than 2 prior chemotherapy regimens allowed

- Same chemotherapy combination given for first line and second line therapy considered
2 regimens

- At least 6 weeks since prior chemotherapy

- No prior high-dose chemotherapy and stem cell transplantation

- No other concurrent cytotoxic chemotherapy

Endocrine therapy:

- No concurrent corticosteroids

Radiotherapy:

- No prior radiotherapy to greater than 25% of functioning bone marrow

- At least 4 weeks since prior radiotherapy (except low-dose, non-myelosuppressive
radiotherapy) and recovered

- No concurrent radiotherapy to sole site of measurable disease

Surgery:

- At least 2 weeks since prior major surgery

Other:

- No other concurrent investigational anticancer agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Joseph M. Connors, MD

Investigator Role:

Study Chair

Investigator Affiliation:

British Columbia Cancer Agency

Authority:

United States: Federal Government

Study ID:

I127

NCT ID:

NCT00005074

Start Date:

January 2000

Completion Date:

September 2008

Related Keywords:

  • Lymphoma
  • stage I mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • stage II mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

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