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Therapeutic Areas: Oncology | Hematology | Immunology
Disease Category: Lymphoma
Location: United States, IL

Clinical Trial Details

Overview

Research Study Summary

S0816 - Phase II Intergroup A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma using Interim FDG-PET Imaging

Purpose

This study is investigational and is being done to find out if it is possible to use early periodic PET scans to identify those patients who are not responding to a combination of standard chemotherapy called "ABVD" (the drugs doxorubicin, bleomycin, vinblastine and dacarbazine). This approach would allow an earlier switch to a more intensive combination chemotherapy called "BEACOPP" (the drugs bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone). We would like to find out if the experimental treatment of switching from ABVD to BEACOPP using periodic PET scanning will improve the chances that your Hodgkin lymphoma will be cured. We also want to compare what kind of side effects this experimental treatment can cause and how often they occur.

Patient Inclusion Criteria:

  • Pts must have untreated Stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich or lymphocyte depleted.
  • Pts must be age 18-60, inclusive.
  • Pts must have bidimensionally measurable disease.
  • Pts must have unilateral or bilateral bm biopsy.
  • Pts must have CT scan of chest/abdomen and pelvis, and baseline FDG-PET scan.
  • Pts must have Zubrod PS of 0-2. S
  • Pts who are immune to Hep B are eligible.
  • Pts must not require continuous supplemental oxygen.
  • Pts must not have prior solid organ transplant.
  • Pts must not have prior malignancy except adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer (currently in complete remission) or any other cancer from which the pt has been disease-free for 5 years.
  • Pts must not be pregnant or nursing.
  • Women/men of reproductive potential must agree to use effective contraception during study and for at least 6 months after completion of therapy.

Patient Exclusion Criteria:

  • Nodular lymphocyte predominant Hodgkin is not eligible.
  • Pts must not have prior chemotherapy, radiation or antibody therapy for lymphoma.
  • Pts with history of hypertension or cardiac symptoms must have MUGA or ECHO with no significant abnormalities and cardiac EF >/= 45%. Pts must not be sero-positive for Hep B or Hep C.
  • HIV+ pts must not have multi-drug resistant HIV, CD4 counts <350/mcl or other concurrent AIDS-defining conditions.
  • Pts must not have significant lung disease with abnormal LFTs (DLCO >25% below predicted after correction for hemoglobin) unless attributable to lymphoma.
  • Pts must not require continuous supplemental oxygen.
  • Pts must not have prior solid organ transplant.
  • Pts must not have prior malignancy except adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer (currently in complete remission) or any other cancer from which the pt has been disease-free for 5 years.
  • Pts must not be pregnant or nursing.
  • Women/men of reproductive potential must agree to use effective contraception during study and for at least 6 months after completion of therapy.

To Learn more
Phase

3

Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Facility Type

N/A

Contact

Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071

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If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 183151

Date Last Changed: July 17, 2013


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