Clinical trial NCT01304849: Use of Interim PET Scan to Modify Therapy in Advanced Hodgkin's Lymphoma in Order to Improve Outcomes
Official title: Phase II Study of Interim PET-CT Scan-guided Response Adapted Therapy in Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hodgkin's Lymphoma
Keywords: Hodgkin's Lymphoma
PET CT scan
Escalated BEACOPP
ABVD
Response adapted therapy
Lead sponsor: Cancer Institute WIA
Sponsor class: OTHER
First posted: 2011-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current standard treatment for advanced Hodgkin's lymphoma 6-8 cycles of ABVD chemotherapy-this cures 70-80% patients. Those not cured after 8 cycles of ABVD have a poor outcome (\<10% survival). More intensive chemotherapy like Escalated BEACOPP (EB) achieve higher cure rates have more side effects. Hence the investigators propose to use Interim PET CT scan (done after 2 cycles of ABVD) for early identification of poor responders (it is known that those with interim PET positive disease have a cure rate of less than 10-15% if continued with ABVD alone) and to use EB selectively in this population in an attempt to improve treatment outcomes - at the same time to limit side effects of therapy.

Thus, this study is an attempt to improve the outcome in the small subset of poor responders to ABVD chemotherapy by the early use of Escalated BEACOPP chemotherapy


Eligibility criteria: Inclusion Criteria:

* Age 12-65 years old
* Newly diagnosed histology proven patients of advanced HL (stage IIb, III and IV)
* Patients' performance status ECOG 0-2
* Normal hematopoetic parameters except if due to marrow involvement by disease (WBC \> 4000/cmm, Platelet count \> 100,000/cmm)
* No uncontrolled hepatitis B/C infection; and normal LFT values with s -Bilirubin, SGOT and SGPT not more than 2.5 times upper limit of normal (unless initially due to liver involvement by disease)
* Serum Creatinine ≤ 2mg/dL unless elevated due to involvement by disease
* Cardiovascular/ Metabolic: No severe cardiac disease that would limit normal life expectancy or preclude study. LVEF at least 50%; Controlled blood glucose if diabetic; controlled Blood pressure if hypertensive
* Pulmonary: No severe pulmonary disease that would limit normal life expectancy or preclude study
* Others: HIV negative status; No prior haematological cancers or chemotherapy or radiation therapy in the past

Exclusion Criteria:

* Pregnancy
* Nursing mothers

Primary outcomes:
measure: Efficacy of interim PET guided therapy strategy interms of EFS in advanced HL
timeFrame: Once in a year
Secondary outcomes:
measure: Toxicity of escalated BEACOPP
timeFrame: 6 months
Other outcomes:
Locations:
city: Chennai
country: India
facility: Department of Medical Oncology, Cancer Institute (WIA), Adyar
state: Tamil Nadu
Study officials:
affiliation: Cancer Institute (WIA) , Adyar, Chennai
name: Prasanth Ganesan, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ganesan P, Rajendranath R, Kannan K, Radhakrishnan V, Ganesan TS, Udupa K, Lakshmipathy KM, Mahajan V, Sundersingh S, Rajaraman S, Krishnakumar R, Sagar TG. Phase II study of interim PET-CT-guided response-adapted therapy in advanced Hodgkin's lymphoma. Ann Oncol. 2015 Jun;26(6):1170-1174. doi: 10.1093/annonc/mdv077. Epub 2015 Feb 20.