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



Status:Terminated
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/2/2018
Start Date:October 2008
End Date:May 23, 2011

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

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).

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.

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
We found this trial at
1
site
New York, New York 10021
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from
New York, NY
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