Vorinostat With or Without Isotretinoin in Treating Young Patients With Recurrent or Refractory Solid Tumors, Lymphoma, or Leukemia

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00217412
Phase
PHASE1
Status
Completed

Conditions

  • Childhood Acute Promyelocytic Leukemia (M3)
  • Childhood Atypical Teratoid/Rhabdoid Tumor
  • Childhood Burkitt Lymphoma
  • Childhood Chronic Myelogenous Leukemia
  • Childhood Diffuse Large Cell Lymphoma
  • Childhood Immunoblastic Large Cell Lymphoma
  • Juvenile Myelomonocytic Leukemia
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
  • Recurrent Childhood Grade III Lymphomatoid Granulomatosis
  • Recurrent Childhood Large Cell Lymphoma
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Recurrent Childhood Medulloblastoma
  • Recurrent Childhood Small Noncleaved Cell Lymphoma
  • Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor
  • Recurrent Neuroblastoma
  • Recurrent/Refractory Childhood Hodgkin Lymphoma
  • Relapsing Chronic Myelogenous Leukemia
  • Unspecified Childhood Solid Tumor, Protocol Specific

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • vorinostat — DRUG
    Given orally
  • isotretinoin — DRUG
    Given orally

Study Details

This phase I trial is studying the side effects and best dose of vorinostat when given together with isotretinoin in treating young patients with recurrent or refractory solid tumors, lymphoma, or leukemia. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Isotretinoin may cause cancer cells to look more like normal cells, and to grow and spread more slowly. Giving vorinostat together with isotretinoin may be an effective treatment for cancer.

Key Dates

Start date
Aug 31, 2005
Status verified
Apr 2013
Primary completion
Sep 30, 2009
Completion
Sep 30, 2009

Study Design

Enrollment
60 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I
    Group 1 (solid tumor or lymphoma patients): Patients receive oral SAHA once daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients may be treated at the MTD.
  • Experimental: Arm II
    Group 2 (leukemia patients): Patients receive SAHA as in group 1 at the MTD.
  • Experimental: Arm III
    Group 3 (select solid tumor patients): Patients receive oral isotretinoin twice daily on days 1-14. Patients also receive SAHA once daily on days 1-28 OR once on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.The MTD of SAHA is determined as in group 1. An additional 6 patients may be treated at the MTD.

Primary Outcome Measure

Maximum tolerated dose (MTD) defined as the maximum dose at which fewer than one-third of patients experience dose-limiting toxicities DLT graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Oncology GroupPhiladelphiaPennsylvania19104-

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By research site
Children's Oncology Group· Philadelphia, PA

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