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Pilot Study of Rituximab, High Dose Cyclophosphamide, and GM-CSF Based Immunotherapy for Relapsed Hodgkin's Lymphoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

Pilot Study of Rituximab, High Dose Cyclophosphamide, and GM-CSF Based Immunotherapy for Relapsed Hodgkin's Lymphoma


OBJECTIVES:

Primary

- Determine the safety and tolerability of rituximab and high-dose cyclophosphamide
followed by vaccine therapy comprising an allogeneic vaccine that expresses Hodgkin's
tumor antigens and sargramostim (GM-CSF) (KGEL vaccine) as salvage therapy in patients
with relapsed Hodgkin lymphoma.

- Determine the immunologic response to this vaccine in these patients.

Secondary

- Determine the 3-year relapse-free and overall survival of patients treated with this
regimen.

- Determine the patterns of cellular immune reconstitution in patients treated with this
regimen.

OUTLINE: This is an open-label study.

Patients receive rituximab IV on days -10 and -7 and then on days 29, 36, 43, and 50 (weeks
4-7) and high-dose (transplant-dose) cyclophosphamide IV on days -3 to 0 without stem cell
rescue. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 6 and
continuing until blood counts recover. Patients also receive vaccine therapy comprising an
allogeneic vaccine that expresses Hodgkin's tumor antigens and sargramostim (GM-CSF) (KGEL
vaccine) intradermally on day 1, and weeks 4, 8, 12, 16, and 24.

After completion of high-dose cyclophosphamide, patients are followed every 3 months for 3
years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed classical Hodgkin's lymphoma

- Relapsed disease with achievement of at least a partial response or a metabolic
response to most recent salvage therapy

- No primary induction failure, defined as disease progression during or within 2
months after completion of first-line therapy

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 75,000/mm^3

Hepatic

- Bilirubin ≤ 2.0 mg/dL* NOTE: *Unless due to lymphoma or Gilbert's syndrome

Renal

- Creatinine ≤ 2.0 mg/dL

Cardiovascular

- Ejection fraction ≥ 45% by echocardiogram or MUGA

Pulmonary

- DLCO ≥ 50% of predicted (corrected for alveolar volume)

Immunologic

- No known HIV positivity

- No active infection requiring oral or IV antibiotics

- No autoimmune or other disease requiring long-term systemic steroids or other
long-term immunosuppressants

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to tolerate high-dose therapy

- No other malignancy within the past 3 years except basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior bone marrow transplantation

Endocrine therapy

- Not specified

Radiotherapy

- Concurrent radiotherapy for disease progression after high-dose cyclophosphamide
allowed at the discretion of the principal investigator

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability

Safety Issue:

Yes

Principal Investigator

Yvette L. Kasamon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

J0528 , CDR0000441037

NCT ID:

NCT00134082

Start Date:

July 2005

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410