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Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma

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Trial Conditions
  • Lymphoma
What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells and allow doctors to save the part of the body where the cancer started. Comparing results of diagnostic procedures, such as PET scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This phase II trial is studying how well chemotherapy based on PET scan works in treating patients with stage I or stage II Hodgkin lymphoma.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18  - 60 

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- Histologically confirmed* Hodgkin lymphoma

- Clinical stage IA, IB, IIA, or IIB disease according to the modified Ann Arbor
Staging Classification system

- Subclassified according to the WHO modification of the Rye Classification

- "E" extension allowed provided all other criteria have been met NOTE: *Pathology
materials must be submitted within 60 days of study registration. Core-needle
biopsies are acceptable provided they contain adequate tissue for primary
diagnosis and immunophenotyping. Fine-needle aspirates not allowed. If multiple
specimens are available, submit the most recent.

- No nodular lymphocyte-predominant Hodgkin lymphoma

- No mediastinal mass > 0.33 maximum intrathoracic diameter by standing
postero-anterior chest x-ray or peripheral or retroperitoneal adenopathy > 10 cm in
its largest diameter

- Measurable disease by physical examination or imaging studies

- Any tumor mass measurable in two dimensions and > 1 cm (or 1.5 cm if 0.5 cm
slices are used, as in spiral CT scans) allowed

- Lesions that are considered intrinsically non-measurable include:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Lymphangitis cutis/pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Lesions that are situated in a previously irradiated area

PATIENT CHARACTERISTICS:

- Performance status 0-2

- ANC ≥ 1,000/μL

- Platelet count ≥ 100,000/μL

- Serum creatinine ≤ 2 mg/dL

- Bilirubin ≤ 2 mg/dL

- AST ≤ 2 times upper limit of normal

- LVEF normal by ECHO or MUGA

- DLCO ≥ 60% with no symptomatic pulmonary disease

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Patients with known HIV allowed provided they have CD4 counts ≥ 350/mcL

- Patients must not have multi-drug resistant HIV infections (i.e., concurrent
AIDS-defining conditions)

- An HIV test is required for patients with a history of IV drug abuse or any
behavior associated with an increased risk of HIVinfection

- No "currently active" second malignancy other than nonmelanoma skin cancers

- Patients are not considered to have a "currently active" malignancy provided
they have completed therapy and are considered by their physician to be at < 30%
risk of relapse

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior chemotherapy or radiotherapy for Hodgkin lymphoma

- 1 course of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) allowed
and will be considered the first course

Gender: Both
Steward Physician(s)
  • David J. Straus, MD
Facilities
  • St. Elizabeth's Medical Center - Recruiting
Trial Interventions
Biological
  • bleomycin sulfate
Drug
  • ABVD regimen
  • BEACOPP regimen
  • cyclophosphamide
  • dacarbazine
  • doxorubicin hydrochloride
  • etoposide
  • prednisone
  • procarbazine hydrochloride
  • vinblastine sulfate
  • vincristine sulfate
Other
  • laboratory biomarker analysis
Procedure
  • computed tomography
Radiation
  • fludeoxyglucose F 18
  • radiation therapy
For more information about this trial, contact

Dorcas Chi

Phone: 617-789-3000

Dorcas D. Chi

Phone: (617) 789-3000


Physician Researcher

Investigator Name:

  • David J. Straus, MD

Other Information

Sponsor: Cancer and Leukemia Group B
Phase: Phase 2
Trial ID: NCT01132807
Volunteers:  Not Accepting Healthy Volunteers

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