Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00001430
Other study ID # 950073
Secondary ID 95-C-0073
Status Completed
Phase Phase 2
First received November 3, 1999
Last updated March 3, 2008
Start date February 1995
Est. completion date January 2002

Study information

Verified date January 2002
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This is a randomized study of combination chemotherapy (EPOCH II) versus EPOCH II and immunotherapy with peripheral blood stem cells (PBSC) and IL-2 in patients with relapsed Hodgkin's and non-Hodgkin's lymphomas, and untreated patients with low-grade non-Hodgkin's lymphomas. The chemotherapy entails the administration of multiple cycles of infusional doxorubicin, etoposide and vincristine chemotherapy (total of 3), alternating with cycles of high-dose cyclophosphamide (3 cycles). Patients will be randomized, on a 2:1 basis, to either receive only chemotherapy or to undergo a PBSC harvest with PBSC reinfusion and IL-2 following the last cycle of chemotherapy. In all patients, immunological monitoring for NK/LAK activity, T cell number and function will be performed. The therapy is specifically targeted for patients who would be candidates for high-dose chemotherapy with stem cell support.


Description:

This is a randomized study of combination chemotherapy (EPOCH II) versus EPOCH II and immunotherapy with peripheral blood stem cells (PBSC) and IL-2 in patients with relapsed Hodgkin's and non-Hodgkin's lymphomas, and untreated patients with low-grade non-Hodgkin's lymphomas. The chemotherapy entails the administration of multiple cycles of infusional doxorubicin, etoposide and vincristine chemotherapy (total of 3), alternating with cycles of high-dose cyclophosphamide (3 cycles). Patients will be randomized, on a 2:1 basis, to either receive only chemotherapy or to undergo a PBSC harvest with PBSC reinfusion and IL-2 following the last cycle of chemotherapy. In all patients, immunological monitoring for NK/LAK activity, T cell number and function will be performed. The therapy is specifically targeted for patients who would be candidates for high-dose chemotherapy with stem cell support.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date January 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Patients must be between 18 and 70 years old.

All stages of patients with low-, intermediate- or high-grade non-Hodgkin's lymphomas, or Hodgkin's disease who have disease following standard chemotherapy.

Stage II-IV patients with previously untreated low-grade lymphoma or untreated low-grade with progression.

Patients must have received less than or equal to 2 prior combination chemotherapy regimens, no combination chemotherapy refractory disease, no high-dose chemotherapy with stem cell rescue, and may not have CNS involvement by lymphoma.

Pathology slides must be reviewed and a diagnosis of lymphoma confirmed by the Hematopathology Section, Laboratory of Pathology, NCI.

No patients with a history of coronary artery disease with angina pectoris and/or an ejection fraction less than 42 percent.

Serum creatinine clearance greater than 50 cc/min, bilirubin less than 2.5 u and AST/ALT less than 2x normal, absolute neutrophil count greater than 1000/mm(3) and platelet count greater than or equal to 100,000/mm(3) unless due to respective organ involvement by tumor.

Patients must have an ECOG performance status less than or equal to 2.

Patients must be HIV negative.

Pregnant women will be excluded.

Patients must be able to give informed consent.

Patients who, in the opinion of the principal investigator, are poor psychiatric or medical risks because of non-malignant systemic disease will be excluded.

A completed eligibility form.

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment


Intervention

Procedure:
PBSC

Drug:
IL-2

EPOCH II


Locations

Country Name City State
United States National Cancer Institute (NCI) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Mackall CL, Granger L, Sheard MA, Cepeda R, Gress RE. T-cell regeneration after bone marrow transplantation: differential CD45 isoform expression on thymic-derived versus thymic-independent progeny. Blood. 1993 Oct 15;82(8):2585-94. — View Citation

Vose JM, Anderson JR, Kessinger A, Bierman PJ, Coccia P, Reed EC, Gordon B, Armitage JO. High-dose chemotherapy and autologous hematopoietic stem-cell transplantation for aggressive non-Hodgkin's lymphoma. J Clin Oncol. 1993 Oct;11(10):1846-51. — View Citation

Wilson WH, Bryant G, Bates S, Fojo A, Wittes RE, Steinberg SM, Kohler DR, Jaffe ES, Herdt J, Cheson BD, et al. EPOCH chemotherapy: toxicity and efficacy in relapsed and refractory non-Hodgkin's lymphoma. J Clin Oncol. 1993 Aug;11(8):1573-82. — View Citation

See also
  Status Clinical Trial Phase
Completed NCT01665768 - Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma Phase 2
Completed NCT01188798 - Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies Phase 3
Completed NCT00975975 - Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer Phase 2
Completed NCT00150462 - Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies Phase 1
Completed NCT00606437 - Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants Phase 1
Completed NCT02856646 - Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices
Completed NCT01458288 - A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease Phase 2
Completed NCT00990587 - Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy Phase 1
Terminated NCT00594308 - In-Vivo Activated T-Cell Depletion to Prevent GVHD N/A
Completed NCT00469729 - Efficacy and Safety Study of StemEx®, to Treat Subjects With High Risk Hematologic Malignancies, Following Myeloablative Therapy Phase 2/Phase 3
Completed NCT00552825 - Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years Old Children N/A
Completed NCT00165438 - Pulmonary Function in Patients With Hodgkin's Disease Receiving Bleomycin-Based Chemotherapy N/A
Terminated NCT00176930 - Stem Cell Transplant for Hematological Malignancy N/A
Recruiting NCT02007811 - Open-label Clinical Trial to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates for Immune Reconstitution After Allogeneic Stem Cell Transplantation Measured as Response to a Antedated Single Vaccination Phase 1/Phase 2
Completed NCT01221857 - Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies Phase 1/Phase 2
Completed NCT00569842 - Investigation of the Cylex® ImmuKnow® Assay N/A
Completed NCT00665314 - Evaluation of the Safety and Efficacy of the Addition of AMD3100 to a G-CSF Mobilization Regimen in Patients With Lymphoma (NHL and HD) and Multiple Myeloma (MM). Phase 2
Completed NCT00256191 - Study of TPI 287 Administered Every 21 Days in Patients With Advanced Malignancies Phase 1
Completed NCT00284804 - A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease Phase 2
Completed NCT00396201 - AMD3100 (Plerixafor) Added to a Mobilizing Regimen of Granulocyte-colony Stimulating Factor (G-CSF) to Increase the Number of Peripheral Blood Stem Cells (PBSCs) in Patients With Hodgkin's Disease Phase 2