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Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate (PALANGI3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01046487
First received: January 11, 2010
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to determine the maximum tolerated dose of imatinib mesylate, given in association with a fixed dose of cyclophosphamide (50 mg bid).


Condition Intervention Phase
Cancer
Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 1 )
Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 2)
Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 3)
Procedure: Blood sampling
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate in Patient With Rare Tumor (Phase I Study)

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • For safety: NCI-CTCAE scale version 3.0 [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • For anti tumoral efficiency : RECIST criteria [ Time Frame: 70 days ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: January 2009
Study Completion Date: February 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 1 )

    CYCLE 1 (42 days):

    • Day 1 to 14 Imatinib mesylate : 400 mg/day, per os
    • Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 400 mg/day, per os

    NEXT CYCLE (28 days):

    Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 400 mg/day, per os

    Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 2)

    CYCLE 1 (42 days):

    • Day 1 to 14 Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening) per os
    • Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening) per os

    NEXT CYCLE (28 days):

    Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening)per os

    Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 3)

    CYCLE 1 (42 days):

    • Day 1 to 14 Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening) per os
    • Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening) per os

    NEXT CYCLE (28 days):

    Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening)per os

    Procedure: Blood sampling

    ONLY FOR CYCLE 1, at day 15 and day 28 :

    11 sampling for dosing level 1 (pre-dose, imatinib mesylate + 30 min, +1, +2, +3, +4, +6, +10, +12 , +24 hours, cyclophosphamide + 12 hours) 10 sampling for the next dosing level (pre-dose, imatinib mesylate + 30 min, +1, +2, +3, +4, +6, +10, +12,cyclophosphamide + 12 hours)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rare tumor
  • metastatic disease or locally advanced disease, inoperable, with no standard treatment
  • At least 28 days since the prior treatment
  • Measurable disease with at least one measurable lesion

Exclusion Criteria:

  • Medullary insufficiency
  • Cystitis, haemorrhagic cystitis
  • Hepatic porphyria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046487

Locations
France
Institut Bergonié
Bordeaux, France, 33076
Centre Oscar Lambret
Lille, France, 59020
Centre Léon Bérard
Lyon, France, 69008
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Antoine ADENIS, MD, PhD Centre Oscar Lambret
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01046487     History of Changes
Other Study ID Numbers: PALANGI-3 0804
Study First Received: January 11, 2010
Last Updated: June 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Oscar Lambret:
dermatofibrosarcoma
cylindroma
choroid melanoma
gastrointestinal stroma tumor
chordoma
ocular melanoma
conjunctival melanoma
malignant melanoma of the anus
gastric melanoma
desmoid tumor

Additional relevant MeSH terms:
Cyclophosphamide
Imatinib
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014