Use of Interim PET Scan to Modify Therapy in Advanced Hodgkin's Lymphoma in Order to Improve Outcomes

Hodgkin's Lymphoma Clinical Trial

Official title:

Phase II Study of Interim PET-CT Scan-guided Response Adapted Therapy in Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304849
• Other study ID #: CIA-HL-1
• Status: Completed
• Phase: N/A
• First received: February 25, 2011
• Last updated: February 2, 2015
• Start date: January 2011
• Est. completion date: September 2013

Study information

• Verified date: February 2015
• Source: Cancer Institute WIA
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma

Intervention

Drug:
• Escalated BEACOPP
Escalated BEACOPP chemotherapy will be delivered for those patients who are interim PET CT positive after 2 cycles of ABVD chemotherapy. The patients will receive 2-4 cycles of Escalated BEACOPP once in 3 weeks. The cycles will be delivered as follows: Bleomycin 10mg/m2 IV in day 8, Etoposide 200mg/m2 Day 1 to Day 3, Adriamycin 35mg/m2 on Day 1 IV, Cyclophosphamide 1200mg/m2 on Day 1 IV, Vincristine 1.4mg/m2 on Day 8 IV, Cap Procarbazine 100mg/m2 Day 1 to Day 7 PO, T Prednisolone 40mg D1-D7 of a 21 day cycle. With Inj Mesna 400mg/m2 0, 4 and 8 hours on the day of Cyclophosphamide Inj G-CSF will be started routinely from Day 9 till recovery of Absolute neutrophil counts =5000/cmm or Total WBC counts= 8000/cmm

Locations

Country	Name	City	State
India	Department of Medical Oncology, Cancer Institute (WIA), Adyar	Chennai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute WIA

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of interim PET guided therapy strategy interms of EFS in advanced HL	This is a phase II design looking at the efficacy of response adapted therapy delivering Esc BEACOPP in select patients with positive interim PET CT while PET negative patients continue to receive ABVD	Once in a year	No
Secondary	Toxicity of escalated BEACOPP		6 months	Yes