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Melanoma (Skin)Phase 2NCT00005971

Flavopiridol in Treating Patients With Metastatic Malignant Melanoma

A Phase 2 study testing alvocidib in people with Melanoma (Skin), run by NCIC Clinical Trials Group at 50 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 tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have metastatic malignant melanoma. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Melanoma (Skin)
What is being tested?
alvocidib
How many people
17 participants
Where
50 sitesCanada
Study dates
4 Jul 2000to 21 Dec 2009
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 confirmed metastatic malignant melanoma not amenable to standard curative therapies
  • No prior regional or systemic therapy for metastatic disease
  • Measurable disease
  • At least 20 mm by conventional techniques OR
  • At least 10 mm by spiral CT scan
  • Bone lesions not considered measurable
  • No known CNS metastases

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 100,000/mm3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than ULN

Cardiovascular:

  • If history of cardiac disease, ejection fraction greater than 50%
  • No clinically significant cardiac symptomology

Pulmonary:

  • If history of pulmonary disease, FEV1, FVC, and TLC greater than 60% predicted and DLCO greater than 50% predicted
  • No clinically significant pulmonary symptomology

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other concurrent serious disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior adjuvant immunotherapy allowed
  • No prior immunotherapy for metastatic disease

Chemotherapy:

  • No prior chemotherapy for metastatic disease
  • No other concurrent chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior adjuvant hormonal therapy

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered
  • Must have measurable disease outside irradiated area OR
  • Evidence of progression or new lesions in irradiated area
  • No more than 25% of functioning bone marrow irradiated
  • No concurrent radiotherapy to sole site of measurable disease

Surgery:

  • At least 4 weeks since prior major surgery

Other:

  • No other concurrent anticancer therapy or investigational anticancer agents

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

Canada50 sites

  • Royal Victoria Hospital, Barrie

    Barrie, Ontario, L4M 6M2

  • William Osler Health Centre

    Brampton, Ontario, L6W 2Z8

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Queen Elizabeth Hospital, PEI

    Charlottetown, Prince Edward Island, C1A 8T5

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Northeastern Ontario Regional Cancer Centre, Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Hamilton and Disrict Urology Association

    Hamilton, Ontario, L8N 1T8

  • Centre Hospitalier Regional de Lanaudiere

    Joliette, Quebec, J6E 6J2

  • Lethbridge Cancer Clinic

    Lethbridge, Alberta, T1J 1W5

  • London Health Sciences Centre

    London, Ontario, N6A 4G5

  • Trillium Health Centre

    Mississauga, Ontario, L5B 1B8

  • Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • Moncton Hospital

    Moncton, New Brunswick, E1C 6ZB

  • Doctor Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Centre Hospitalier de l'Universite' de Montreal

    Montreal, Quebec, H2W 1T8

  • Hotel Dieu de Montreal

    Montreal, Quebec, H2W 1T8

  • Hopital Du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • York County Hospital

    Newmarket, Ontario, L3Y 2P9

  • North York General Hospital, Ontario

    North York, Ontario, M2E 1K1

  • Male Health Centre/CMX Research Inc.

    Oakville, Ontario, L6H 3PI

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 1C4

  • Penticton Regional Hospital

    Penticton, British Columbia, V2A 3G6

  • Peterborough Oncology Clinic

    Peterborough, Ontario, K9H 7B6

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • Hopital du Saint-Sacrament, Quebec

    Québec, Quebec, G1S 4L8

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Scarborough Hospital - General Site

    Scarborough Village, Ontario, M1P 2V5

  • Hotel Dieu Health Sciences Hospital - Niagara

    St. Catharines, Ontario, L2R 5K3

  • Newfoundland Cancer Treatment and Research Foundation

    St. John's, Newfoundland and Labrador, A1B 3V6

  • L'Hopital Laval

    Ste-Foy, Quebec, G1V 4G5

  • Northwestern Ontario Regional Cancer Centre, Thunder Bay

    Thunder Bay, Ontario, P7A 7T1

  • Toronto East General Hospital

    Toronto, Ontario, M4C 3E7

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital - Toronto

    Toronto, Ontario, M5B 1W8

  • Mount Sinai Hospital - Toronto

    Toronto, Ontario, M5G 1X5

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Women's College Campus, Sunnybrook and Women's College Health Science Center

    Toronto, Ontario, M5S 1B6

  • Saint Joseph's Health Centre - Toronto

    Toronto, Ontario, M6R 1B5

  • Prostate Centre at Vancouver General Hospital

    Vancouver, British Columbia, V5Z 3J5

  • St. Paul's Hospital - Vancouver

    Vancouver, British Columbia, V6Z 1Y6

  • G. Steinhoff Clinical Research

    Victoria, British Columbia, V8V 3N1

  • Humber River Regional Hospital

    Weston, Ontario, M9N 1N8

  • Cancer Care Ontario - Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

Other trials in Canada

About this study

Official title: A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma

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

PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have metastatic malignant melanoma.

Read the detailed description

OBJECTIVES:

  • Assess the efficacy of flavopiridol in patients with previously untreated metastatic malignant melanoma.
  • Assess the toxicity of this treatment in these patients.
  • Assess the time to progression, early progression rate, and response duration in these patients when treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment continues every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks, and then every 3 months until disease progression or death.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.

Conditions
Melanoma (Skin)
Being tested
alvocidib
Keywords
stage IV melanoma
Medical subject headings
Melanoma

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 posted21 May 2003 (estimated)
  2. Study start4 Jul 2000
  3. Primary completion24 Aug 2001
  4. Study completion21 Dec 2009

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005971
Sponsor's protocol ID
I137
Other IDs
CAN-NCIC-IND137, NCI-NCIC-137, CDR0000067955
Status last verified
Apr 2020
First submitted
5 Jul 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

  • Burdette-Radoux S, Tozer RG, Lohmann RC, Quirt I, Ernst DS, Walsh W, Wainman N, Colevas AD, Eisenhauer EA. Phase II trial of flavopiridol, a cyclin dependent kinase inhibitor, in untreated metastatic malignant melanoma. Invest New Drugs. 2004 Aug;22(3):315-22. doi: 10.1023/B:DRUG.0000026258.02846.1c.

    PubMed 15122079

  • Burdette-Radoux S, Tozer RG, Lohmann R, et al.: NCIC CTG phase II study of flavopiridol in patients with previously untreated metastatic malignant melanoma (IND.137). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1382, 2002.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing alvocidib in people with Melanoma (Skin), run by NCIC Clinical Trials Group at 50 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 50 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 NCT00005971, which also lists 2 linked publications.

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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