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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Cancer Institute WIA.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Prasanth Ganesan, Cancer Institute WIA
ClinicalTrials.gov Identifier:
NCT01304849
First received: February 25, 2011
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention
Hodgkin's Lymphoma
Drug: Escalated BEACOPP

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Interim PET-CT Scan-guided Response Adapted Therapy in Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Cancer Institute WIA:

Primary Outcome Measures:
  • toxicity of escalated BEACOPP in advanced hodgkin's lymphoma with interim PET scan positivity [ Time Frame: Once every 6 months ] [ Designated as safety issue: Yes ]

    this is a pilot study looking at the feasibility of delivering escalated Beacopp in the Indian population where there is no data on the delivery of the same. So the investigators are soliciting a group of patients who have a high risk of failure as defined by interim PET positivity after 2 cycles of ABVD chemotherapy.

    The investigators look at toxicity issues of this high intensity protocol



Secondary Outcome Measures:
  • Efficacy of "response adapted" therapy in Hodgkin's lymphoma [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    With the use of Escalated BEACOPP in advanced HL who are PET CT positive at the end of 2 cycles of ABVD chemotherapy the investigators hope to improve the outcome in terms of event free as well as overall survival in these patients who have historically had a poor outcome.


Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304849

Contacts
Contact: Prasanth Ganesan, MD +91-44-24910574 pg1980@gmail.com
Contact: Tenali G Sagar, MD +91-44-24911526 tgsagar@yahoo.com

Locations
India
Department of Medical Oncology, Cancer Institute (WIA), Adyar Recruiting
Chennai, Tamil Nadu, India, 600020
Contact: Prasanth Ganesan, MD    +91-44-24910574    pg1980@gmail.com   
Contact: Tenali G Sagar, MD    +91-44-24910574    tgsagar@yahoo.com   
Principal Investigator: Prasanth Ganesan, MD,DM         
Sub-Investigator: Tenali G Sagar, MD, DM         
Sponsors and Collaborators
Cancer Institute WIA
Investigators
Principal Investigator: Prasanth Ganesan, MD, DM Cancer Institute (WIA) , Adyar, Chennai
  More Information

No publications provided

Responsible Party: Prasanth Ganesan, Assistant Professor, Cancer Institute WIA
ClinicalTrials.gov Identifier: NCT01304849     History of Changes
Other Study ID Numbers: CIA-HL-1
Study First Received: February 25, 2011
Last Updated: April 11, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Cancer Institute WIA:
Hodgkin's Lymphoma
PET CT scan
Escalated BEACOPP
ABVD
Response adapted therapy

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014