A Phase II Trial of Suberoylanilide Hydroxamic Acid for Recurrent or Primary Refractory Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase II Trial of Suberoylanilide Hydroxamic Acid for Recurrent or Primary Refractory 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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)

Outcome Description:

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.

Outcome Time Frame:

after every 3 cycles on treatment

Safety Issue:

No

Principal Investigator

Mark H. Kirschbaum, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03071

NCT ID:

NCT00132028

Start Date:

September 2005

Completion Date:

July 2011

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • adult lymphocyte depletion Hodgkin lymphoma
  • adult lymphocyte predominant Hodgkin lymphoma
  • adult mixed cellularity Hodgkin lymphoma
  • adult nodular sclerosis Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

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