Pilot Study of Abbreviated Chemotherapy Based on Positron Emission Tomography (PET) Scan in Hodgkin's Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00901303
First received: April 30, 2009
Last updated: September 8, 2010
Last verified: September 2010
  Purpose

The primary objective of the study is to determine the progression-free survival [PFS] at 36 months for patients with Hodgkin lymphoma who achieve a complete metabolic response as demonstrated by a negative fluorodeoxyglucose (FDG)-PET scan after one cycle of ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) who undergo abbreviated ABVD chemotherapy (3 cycles).


Condition Intervention
Hodgkin's Lymphoma
Drug: ABVD chemotherapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Abbreviated Chemotherapy Based on Positron Emission Tomography in Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Progression-free survival [PFS] at 36 months [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2010
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
early stage disease
Drug: ABVD chemotherapy
Adriamycin 25 mg/m2 bleomycin 10 units/m2 vinblastine 6 mg/m2 dacarbazine 375 mg/m on Days 1 and 15 of each 28 day cycle
Group B
advanced stage disease
Drug: ABVD chemotherapy
Adriamycin 25 mg/m2 bleomycin 10 units/m2 vinblastine 6 mg/m2 dacarbazine 375 mg/m on Days 1 and 15 of each 28 day cycle

Detailed Description:

The proposed study is based on the repeated demonstration that patients with Hodgkin lymphoma who attain a negative PET scan early in therapy (after one or 2 cycles of chemotherapy) have a uniformly excellent outcome, with long term disease free survival of 90-95%. We propose to abbreviate chemotherapy in those patients showing a complete metabolic response as measured by FDG-PET after one cycle of ABVD. These patients will undergo two more cycles of ABVD chemotherapy, for a total of 3 cycles. Those patients failing to achieve a complete metabolic response as demonstrated by residual FDG avidity will go off study and be treated as per their primary treating physician.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented classical Hodgkin lymphoma according to the WHO Classification. Nodular lymphocyte predominant Hodgkin lymphoma is excluded
  • No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma
  • Measurable disease must be present either on physical examination or imaging studies. Any tumor mass measurable in two dimensions and > 2 cm is acceptable (or 1.5 cm if 0.5 cm slices are used as in spiral CT scans)
  • Age ≥ 18
  • Patients must have at least one hypermetabolic lesion identifiable on initial PET scan
  • LVEF by ECHO or MUGA within institutional normal limits
  • Initial laboratory data should be compatible with the administration of standard doses of ABVD chemotherapy

Exclusion Criteria:

  • Patient has no known HIV infection
  • Patient is non-pregnant and non-lactating. Due to the teratogenic potential of the agents used in this study, pregnant or nursing women may not be enrolled. Women and men of reproductive potential should agree to use an effective means of birth control
  • No other history of lymphoproliferative disorder or granulomatous disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901303

Contacts
Contact: Rebecca Elstrom, MD ree2001@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Rebecca Elstrom, MD       ree2001@med.cornell.edu   
Principal Investigator: Rebecca Elstrom, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Rebecca Elstrom, MD Weill Medical College of Cornell University
  More Information

Additional Information:
No publications provided

Responsible Party: Rebecca Elstrom, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00901303     History of Changes
Other Study ID Numbers: 0810010015
Study First Received: April 30, 2009
Last Updated: September 8, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014