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Status:

COMPLETED

MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Adult Grade III Lymphomatoid Granulomatosis

Anaplastic Large Cell Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

Phase I trial to study the effectiveness of combining MS-275 with isotretinoin in treating patients who have metastatic or advanced solid tumors or lymphomas. MS-275 may stop the growth of cancer cell...

Detailed Description

PRIMARY OBJECTIVES: I. Determine the dose-limiting toxicity and maximum tolerated dose of MS-275 when administered with isotretinoin in patients with metastatic, progressive, refractory, or unresecta...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically confirmed solid tumor or lymphoma
  • Metastatic, progressive, refractory, or unresectable disease
  • Not amenable to standard curative measures
  • No known brain metastases
  • Performance status - ECOG 0-2
  • More than 3 months
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • WBC ≥ 3,000/mm\^3
  • Hemoglobin \> 9 g/dL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • No suspected Gilbert's syndrome
  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance ≥ 60 mL/min
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No unstable cardiac arryhthmia
  • Able to take and retain oral medications
  • No malabsorption problems
  • No acute or chronic gastrointestinal condition
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception 1 month before, during, and 3 months after study treatment
  • No known HIV positivity
  • No weight loss \> 10% within the past 2 months
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to MS-275 or isotretinoin
  • No other uncontrolled illness
  • No ongoing or active infection
  • No seizure disorder
  • No psychiatric illness or social situation that would preclude study participation
  • More than 4 weeks since prior anticancer vaccine therapy
  • More than 4 weeks since prior anticancer immunotherapy
  • No concurrent anticancer vaccine therapy
  • No concurrent anticancer immunotherapy
  • More than 4 weeks since prior anticancer chemotherapy (6 weeks for nitrosoureas, mitomycin, or other agents known to cause prolonged marrow supression)
  • No concurrent anticancer chemotherapy
  • More than 4 weeks since prior anticancer hormonal therapy except gonadotropin-releasing hormone (GnRH) agonist therapy for non-castrated patients with prostate cancer
  • Concurrent GnRH agonist therapy for non-castrated patients with prostate cancer allowed
  • Concurrent luteinizing hormone-releasing hormone agonist therapy allowed provided there is evidence of tumor progression
  • Concurrent adrenal steroid replacement therapy allowed
  • No concurrent ketoconazole as second-line hormonal treatment for prostate cancer
  • No concurrent corticosteroids except for treatment of refractory nausea or vomiting
  • No other concurrent anticancer hormonal therapy
  • More than 4 weeks since prior anticancer radiotherapy
  • More than 2 weeks since prior palliative radiotherapy
  • No concurrent anticancer radiotherapy
  • More than 4 weeks since prior major surgery
  • Recovered from all prior therapy
  • No prior MS-275
  • No prior oral isotretinoin
  • Isotretinoin for the treatment of acne allowed provided \> 3 years since prior administration
  • More than 4 weeks since other prior anticancer therapy
  • No concurrent tetracycline
  • No concurrent high-dose vitamin A
  • No concurrent valproic acid
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy

Exclusion

    Key Trial Info

    Start Date :

    October 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    24 Patients enrolled

    Trial Details

    Trial ID

    NCT00098891

    Start Date

    October 1 2004

    Last Update

    January 24 2013

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Johns Hopkins University

    Baltimore, Maryland, United States, 21287-8936