Immunotherapy Using Cyclosporine, Interferon Gamma, and Interleukin-2 After High-Dose Myeloablative Chemotherapy With Autologous Stem Cell Transplantation in Treating Patients With Refractory or Relapsed Hodgkin's Lymphoma
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| ClinicalTrials.gov Identifier: NCT00070187 |
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Recruitment Status :
Completed
First Posted : October 7, 2003
Last Update Posted : October 17, 2013
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving immunotherapy using cyclosporine, interferon gamma, and interleukin-2 after stem cell transplantation may help the transplanted cells make an immune response and kill any remaining cancer cells. It is not yet known whether high-dose chemotherapy followed by autologous stem cell transplantation is more effective with or without immunotherapy.
PURPOSE: This randomized phase II/III trial is studying how well high-dose chemotherapy followed by autologous stem cell transplantation, cyclosporine, interferon gamma, and interleukin-2 works and compares it to high-dose chemotherapy followed by autologous stem cell transplantation only in treating patients with refractory or relapsed Hodgkin's lymphoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Biological: aldesleukin Biological: filgrastim Biological: recombinant interferon gamma Drug: carmustine Drug: cyclosporine Drug: cytarabine Drug: etoposide Drug: melphalan Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation | Phase 2 Phase 3 |
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| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 24 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II/III Study of Immunomodulation After High Dose Myeloablative Therapy With Autologous Stem Cell Rescue for Refractory/Relapsed Hodgkin Disease |
| Study Start Date : | November 2003 |
| Actual Primary Completion Date : | June 2005 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Hyperfractionated Involved-Field Radiotion-immunotherapy
Completed prior salvage induction therapy and have not received full tissue tolerance from prior radiotherapy may receive hyperfractionated involved-field radiotherapy twice daily for 7 days. HIGH-DOSE PREPARATIVE REGIMEN: Beginning within 7 days after radiotherapy, carmustine IV over 3 hours on day -6; etoposide IV over 1 hour and cytarabine IV over 1 hour on days -5 to -2; and melphalan IV over 30 minutes on day -1. ASCT: Autologous bone marrow or peripheral blood stem cell transplantation on day 0. Filgrastim (oral or IV) beginning on day 1 and continuing until blood counts recover. IMMUNOTHERAPY: Cyclosporine IV twice daily beginning on day 0 and continuing until the completion of the course of recombinant interferon gamma and interleukin-2. When sufficiently recovered, Aldesleukin once daily for 18 days. |
Biological: aldesleukin
Given IV
Other Names:
Biological: filgrastim Given IV
Other Names:
Biological: recombinant interferon gamma Given IV
Other Names:
Drug: carmustine Given IV
Other Names:
Drug: cyclosporine Given IV
Other Names:
Drug: cytarabine Given IV
Other Names:
Drug: etoposide Given IV
Other Names:
Drug: melphalan Given IV
Other Names:
Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
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Experimental: Hyperfractionated Involved-Field Radiotion-no immunotherapy
Completed prior salvage induction therapy and have not received full tissue tolerance from prior radiotherapy may receive hyperfractionated involved-field radiotherapy twice daily for 7 days. HIGH-DOSE PREPARATIVE REGIMEN: Beginning within 7 days after radiotherapy, carmustine IV over 3 hours on day -6; etoposide IV over 1 hour and cytarabine IV over 1 hour on days -5 to -2; and melphalan IV over 30 minutes on day -1. ASCT: Autologous bone marrow or peripheral blood stem cell transplantation on day 0. Filgrastim (oral or IV) beginning on day 1 and continuing until blood counts recover. |
Biological: filgrastim
Given IV
Other Names:
Drug: carmustine Given IV
Other Names:
Drug: cyclosporine Given IV
Other Names:
Drug: cytarabine Given IV
Other Names:
Drug: etoposide Given IV
Other Names:
Drug: melphalan Given IV
Other Names:
Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
- Incidence of death, excluding death due to disease, during the period of time from day 0 (transplant) through day 100 post transplant [ Time Frame: Day 0 (transplant) through Day 100 (Post transplant) ]Death, excluding death due to disease, during the period of time from Day 0 (transplant) through Day 100 post transplant.
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| Ages Eligible for Study: | up to 30 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Diagnosis of Hodgkin's lymphoma
- Histologically confirmed at original diagnosis AND at relapse or disease progression
- Relapsed or refractory to conventional therapy
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No recurrence without B symptoms or bulky disease at least 1 year after completion of minimal systemic therapy defined by either of the following:
- Stage IA/IIA with nodal disease previously treated with radiotherapy only
- Stage IA/IIA with nodal disease previously treated with less than 3 courses of standard dose chemotherapy
- Concurrently enrolled on the COG-AHOD00P1 salvage chemotherapy study OR received other appropriate salvage therapy (e.g., ifosfamide and vinorelbine)
PATIENT CHARACTERISTICS:
Age
- Under 30
Performance status
- ECOG 0-2 (for adults)
- Lansky 50-100% (for children)
Life expectancy
- At least 2 months
Hematopoietic
- Absolute neutrophil count at least 500/mm^3
Hepatic
- Bilirubin no greater than 1.5 times normal
- SGPT less than 2.5 times normal
Renal
- Creatinine no greater than 1.5 times normal OR
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min/1.73 m^2
Cardiovascular
- Shortening fraction at least 27% by echocardiogram OR
- Ejection fraction at least 50% by MUGA
Pulmonary
- No evidence of dyspnea at rest
- No exercise intolerance
- DLCO at least 50% (patients 8 years of age and over)
Other
- Not pregnant or nursing
- Negative pregnancy test
- No concurrent serious illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Recovered from prior immunotherapy
- At least 1 week since prior antineoplastic biologic agents
- More than 1 week since prior growth factors
- No prior stem cell transplantation
- No other concurrent immunomodulating agents
Chemotherapy
- See Disease Characteristics
- More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
- No other concurrent anticancer chemotherapy
Endocrine therapy
- No concurrent steroids, including dexamethasone as an antiemetic
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
Surgery
- Not specified
Other
- No concurrent participation in another COG therapeutic study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070187
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| Study Chair: | Allen R. Chen, MD, PhD, MHS | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Study Chair: | Sharon L. Gardner, MD | NYU Langone Health |
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00070187 |
| Other Study ID Numbers: |
AHOD0121 CDR0000330135 ( Other Identifier: Clinical Trials.gov ) COG-AHOD0121 ( Other Identifier: Children's Oncology Group ) |
| First Posted: | October 7, 2003 Key Record Dates |
| Last Update Posted: | October 17, 2013 |
| Last Verified: | October 2013 |
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recurrent adult Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma |
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Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Interferons Cytarabine Aldesleukin Interferon-gamma Cyclosporine Etoposide Melphalan Interleukin-2 |
Carmustine Cyclosporins Lenograstim Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antimetabolites, Antineoplastic |