Overview

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

Status:
Terminated
Trial end date:
2011-05-23
Target enrollment:
0
Participant gender:
All
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).
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Weill Medical College of Cornell University
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