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S0517 Vorinostat in Treating Patients With Relapsed or Refractory Advanced Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00132028
First received: August 16, 2005
Last updated: January 4, 2013
Last verified: January 2013
History of Changes

August 16, 2005
January 4, 2013
September 2005
October 2007   (final data collection date for primary outcome measure)
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) [ Time Frame: after every 3 cycles on treatment ] [ Designated as safety issue: No ]
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Not Provided
Complete list of historical versions of study NCT00132028 on ClinicalTrials.gov Archive Site
  • Progression-Free Survival [ Time Frame: after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years. ] [ Designated as safety issue: No ]
    Measured from date of registration to date of first observation of progression or death, or last contact date. Progression is defined as a 50% increase in sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; appearance of a new lesion/site; unequivocal progression of non-measurable disease in the opinion of the treating physician; death due to disease without prior documentation of progression.
  • Overall Survival [ Time Frame: after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years. ] [ Designated as safety issue: No ]
    Measured from date of registration to death, or last contact date
Not Provided
Not Provided
Not Provided
 
S0517 Vorinostat in Treating Patients With Relapsed or Refractory Advanced Hodgkin's Lymphoma
A Phase II Trial of Suberoylanilide Hydroxamic Acid for Recurrent or Primary Refractory Hodgkin's Lymphoma

RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well vorinostat works in treating patients with relapsed or refractory advanced Hodgkin's lymphoma.

OBJECTIVES:

Primary

  • Determine the response rates (complete, complete unconfirmed, and partial) in patients with relapsed or primary refractory advanced Hodgkin's lymphoma treated with vorinostat (SAHA).

Secondary

  • Determine the 1-year progression-free survival and overall survival of patients treated with this drug.
  • Determine the toxicity profile of this drug in these patients.
  • Correlate gene expression profiling of tumor tissue with response in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral vorinostat twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR.

After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 10-18 months.
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
Drug: vorinostat
400 mg/day
Other Name: SAHA
Experimental: SAHA (Vorinostat)
Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
Intervention: Drug: vorinostat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
July 2011
October 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed Hodgkin's lymphoma

    • Any subtype allowed, including lymphocyte predominant Hodgkin's lymphoma
    • Relapsed or primary refractory disease
    • Advanced disease
  • Clear evidence of disease progression OR lack of response after most recent prior therapy, including local radiotherapy
  • Bidimensionally measurable disease
  • No potentially curative treatment (e.g., salvage therapy with chemotherapy or hematopoietic stem cell transplantation [SCT]) exists
  • No clinical evidence of central nervous system (CNS) lymphoma

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • aspartate aminotransferase (SGOT) / alanine aminotransferase (SGPT) < 2.5 times upper limit of normal (ULN)

Renal

  • Creatinine < 2 times ULN

Cardiovascular

  • No myocardial infarction or unstable angina within the past 6 months
  • No stroke within the past 6 months

Immunologic

  • No autologous or allogeneic SCT-related active fungal or viral infection
  • No allogeneic SCT-related active acute graft vs host disease (GVHD) of any grade
  • No allogeneic SCT-related chronic GVHD except mild skin, oral, or ocular GVHD not requiring systemic immunosuppression
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drug

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or stage II cancer in complete remission.

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 3 months since prior autologous SCT that resulted in disease relapse
  • At least 1 year since prior allogeneic SCT that resulted in disease relapse
  • No concurrent biologic therapy
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No initiation of epoetin alfa or darbepoetin alfa (Aranesp®) during study treatment

Chemotherapy

  • No more than 5 prior chemotherapy regimens
  • At least 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin) and recovered

Endocrine therapy

  • No concurrent hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • At least 14 days since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • At least 2 weeks since prior valproic acid or other histone deacetylase inhibitors
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent complimentary or alternative medications
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00132028
NCI-2012-03071, U10CA032102, S0517, CDR0000438779
No
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Study Chair: Mark H. Kirschbaum, MD Beckman Research Institute
Study Chair: Jasmine M. Zain, MD Beckman Research Institute
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP