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

Conditions

• Adult Lymphocyte Depletion Hodgkin Lymphoma
• Adult Lymphocyte Predominant Hodgkin Lymphoma
• Adult Mixed Cellularity Hodgkin Lymphoma
• Adult Nodular Sclerosis Hodgkin Lymphoma
• Recurrent Adult Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• monoclonal antibody SGN-30 — BIOLOGICAL
  Given IV
• placebo — OTHER
  Given IV
• vinorelbine tartrate — DRUG
  Given IV
• pegylated liposomal doxorubicin hydrochloride — DRUG
  Given IV
• gemcitabine hydrochloride — DRUG
  Given IV
• laboratory biomarker analysis — OTHER
  Correlative studies
• pharmacological study — OTHER
  Correlative studies

Study Details

This randomized phase II trial studies the side effects and how well giving monoclonal antibody SGN-30 together with combination chemotherapy works in treating patients with Hodgkin lymphoma that has returned after a period of improvement or did not respond to previous treatment. Monoclonal antibodies, such as SGN-30, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine hydrochloride, vinorelbine tartrate, and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody SGN-30 together with combination chemotherapy may kill more cancer cells and shrink tumors.

Key Dates

Start date

Apr 30, 2006

Status verified

Oct 2014

Primary completion

Sep 30, 2008

Completion

Oct 31, 2014

Study Design

Enrollment

30 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (SGN-30, chemotherapy)
  Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days. No prior stem cell transplant: SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8. Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.
• Active Comparator: Arm II (placebo, chemotherapy)
  Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days. No prior stem cell transplant: SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8. Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.

Primary Outcome Measure

Number of Participants With Overall Response (OR) [ Time Frame: Up to 10 years ]

Locations (1)

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