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LymphomaPhase 2NCT00005074

Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma

A Phase 2 study testing alvocidib in people with Lymphoma, run by NCIC Clinical Trials Group at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have previously untreated or relapsed mantle cell lymphoma. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lymphoma
What is being tested?
alvocidib
How many people
33 participants
Where
4 sitesCanada
Study dates
24 Jan 2000to 22 Sep 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Cancer Care Ontario-Hamilton Regional Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Humber River Regional Hospital

    Weston, Ontario, M9N 1N8

Other trials in Canada

About this study

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

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have previously untreated or relapsed mantle cell lymphoma.

Read the detailed description

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.

Conditions
Lymphoma
Being tested
alvocidib
Keywords
stage I mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma, stage II mantle cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alvocidibDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study start24 Jan 2000
  3. Primary completion20 Feb 2002
  4. Study completion22 Sep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005074
Sponsor's protocol ID
I127
Other IDs
CAN-NCIC-IND127, NCI-100, CDR0000067679
Status last verified
Apr 2020
First submitted
6 Apr 2000
Last updated
9 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kouroukis CT, Belch A, Crump M, Eisenhauer E, Gascoyne RD, Meyer R, Lohmann R, Lopez P, Powers J, Turner R, Connors JM; National Cancer Institute of Canada Clinical Trials Group. Flavopiridol in untreated or relapsed mantle-cell lymphoma: results of a phase II study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2003 May 1;21(9):1740-5. doi: 10.1200/JCO.2003.09.057.

    PubMed 12735303

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing alvocidib in people with Lymphoma, run by NCIC Clinical Trials Group at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005074, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.

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