Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI CALGB-50502 CALGB-50502, NCT00337194

Objectives

1. Determine the complete and partial response rates after treatment with monoclonal antibody SGN-30, gemcitabine, vinorelbine, and pegylated doxorubicin HCl liposome in patients with relapsed or refractory Hodgkin's lymphoma.
2. Assess the time to progression and overall survival of patients treated with this regimen.
3. Evaluate the toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed CD30+ classical Hodgkin's lymphoma, including the following subtypes:
  • Nodular sclerosis
  • Lymphocyte-depleted
  • Lymphocyte-rich
  • Mixed cellularity



• Original diagnostic specimen or specimen from relapse required
  • Core needle biopsy allowed provided there is adequate tissue for primary diagnosis and immunophenotyping
  • Bone marrow biopsy allowed provided nodal biopsy is available
  • No fine needle aspirates



• Relapsed or refractory disease after ≥ 1 prior therapy



• Measurable disease, defined as any lesion that can be accurately measured in ≥ 1 dimension as ≥ 10 mm
  • Nonmeasurable or evaluable disease allowed provided measurable disease is present
    • Nonmeasurable disease includes any of the following:
      • Bone lesions
      • Bone marrow involvement
      • Ascites
      • Pleural/pericardial effusion
      • Lymphangitis cutis/pulmonis



• No nodular lymphocyte-predominant Hodgkin's lymphoma

Prior/Concurrent Therapy:

• At least 3 weeks since prior chemotherapy or radiotherapy and recovered
• Prior autologous, allogeneic, or unrelated stem cell transplantation allowed
• No prior anti-CD30 antibody, gemcitabine, vinorelbine, or pegylated doxorubicin HCl liposome
• No other concurrent chemotherapy
• No concurrent steroids or hormones
  • Steroids given for adrenal failure or hormones administered for nondisease-related conditions (e.g., insulin for diabetes) allowed
• No concurrent dexamethasone, except as needed to treat monoclonal antibody SGN-30 or pegylated doxorubicin HCl liposome infusion reactions, or as an anti-emetic on the day of chemotherapy
• No concurrent palliative radiotherapy
• No concurrent pegfilgrastim

Patient Characteristics:

• ECOG performance status 0-2
• Absolute neutrophil count ≥ 1,200/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 2.0 mg/dL
• Bilirubin ≤ 2.0 mg/dL (in the absence of Gilbert's disease)
• AST ≤ 2.0 times upper limit of normal
• LVEF ≥ 45% by MUGA or ECHO
• DLCO ≥ 50%
• Not pregnant
• Negative pregnancy test
• No nursing during and for 6 months after completion of study treatment
• Fertile patients must use effective contraception during and for 6 months after completion of study treatment
• No uncontrolled angina
• No myocardial infarction within the past 6 months
• No New York Heart Association class II-IV congestive heart failure

Expected Enrollment

A total of 141 patients will be accrued for this study.

Outcomes

Overall response rate
Time to progression
Overall survival
Toxicity

Outline

This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior stem cell transplantation (yes vs no).

• Part 1: Patients receive monoclonal antibody SGN-30 IV over 2 hours, vinorelbine IV over 6-10 minutes, gemcitabine IV over 30 minutes, and pegylated doxorubicin HCl liposome IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days until 10 out of 16 patients complete 1 course in the absence of unacceptable toxicity. Subsequent patients receive treatment on part 2.



• Part 2: Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive monoclonal antibody SGN-30 IV over 2 hours, vinorelbine IV over 6-10 minutes, gemcitabine IV over 30 minutes, and pegylated doxorubicin HCl liposome IV over 90 minutes on days 1 and 8.
  
  
  
  • Arm II (closed to accrual as of 12/4/07): Patients receive placebo IV over 2 hours, vinorelbine IV over 6-10 minutes, gemcitabine IV over 30 minutes, and pegylated doxorubicin HCl liposome IV over 90 minutes on days 1 and 8.
  
  
  

  Treatment in both arms repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 10 years.

Blum KA, Johnson JL, Jung SH, et al.: Serious pulmonary toxicity with SGN-30 and gemcitabine, vinorelbine, and liposomal doxorubicin in patients with relapsed/refractory Hodgkin lymphoma (HL): Cancer and Leukemia Group B (CALGB) 50502. [Abstract] Blood 112 (11): A-232, 2008.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Kristie Blum, MD, Protocol chair		Ph: 614-293-8858
Nancy Bartlett, MD, Protocol co-chair		Ph: 314-362-5654; 800-600-3606

Registry Information
Official Title		A Randomized Double-blinded Placebo Controlled Phase II Study of the Anti-CD30 Antibody, SGN-30 (NSC #731636, IND #100057), in Combination with Gemcitabine, Vinorelbine, and Pegylated Liposomal Doxorubicin (GVD) for Patients with Relapsed/Refractory Hodgkin Lymphoma
Trial Start Date		2006-04-15
Trial Completion Date		2009-05-14 (estimated)
Registered in ClinicalTrials.gov		NCT00337194
Date Submitted to PDQ		2006-04-14
Information Last Verified		2007-12-20
NCI Grant/Contract Number		CA31946

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