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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 30, 2009

Last Updated Date

September 8, 2010

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00901303 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Pilot Study of Abbreviated Chemotherapy Based on Positron Emission Tomography in Hodgkin Lymphoma

Brief Summary

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).

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hodgkin's Lymphoma

Intervention ^ICMJE

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

Study Arm (s)

Group A
early stage disease

Intervention: Drug: ABVD chemotherapy
Group B
advanced stage disease

Intervention: Drug: ABVD chemotherapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Rebecca Elstrom, MD

ree2001@med.cornell.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00901303

Other Study ID Numbers ^ICMJE

0810010015

Has Data Monitoring Committee

Responsible Party

Rebecca Elstrom, MD, Weill Cornell Medical College

Study Sponsor ^ICMJE

Weill Medical College of Cornell University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Rebecca Elstrom, MD

Weill Medical College of Cornell University

Information Provided By

Weill Medical College of Cornell University

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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