Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00722865
Other study ID # 07-388
Secondary ID
Status Terminated
Phase Phase 2
First received July 24, 2008
Last updated September 18, 2017
Start date September 2008
Est. completion date November 2015

Study information

Verified date September 2017
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to determine the effectiveness and safety of Avastin when combined with standard chemotherapy for Hodgkin lymphoma. Avastin works differently than standard chemotherapy drugs. It is a type of protein called an antibody which binds to a substance called VEGF(Vascular Endothelial Growth Factor). VEGF stimulates the growth of the blood vessels that feed tumors and encourages tumor cell growth. VEGF is produced in excess by Hodgkin lymphoma cells, and is associated with a poorer outcome in patients with Hodgkin lymphoma. When the activity of VEGF is interrupted in multiple other cancer types, the blood vessels around the tumor cells die resulting in less nutrient delivery and death to the tumor. Blocking of VEGF has also been shown to improve delivery of chemotherapy to cancer cells, making standard chemotherapy work better. This trial uses Avastin in combination with standard chemotherapy with the goal of improving the cure rate over chemotherapy alone.


Description:

Participants will be given Avastin as well as ABVD (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) intravenously on days 1 and 15 of a 28 day cycle. Participants will receive up to a total of 6 cycles of therapy.


Recruitment information / eligibility

Status Terminated
Enrollment 25
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years of age or older

- Biopsy proven classical Hodgkin lymphoma. Classical Hodgkin lymphoma includes the subtypes of nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted, and classical Hodgkin lymphoma unspecified

- Advanced stage (Stage III or IV) disease

- Measurable disease on cross sectional imaging

- ECOG Performance Status 0-2

- Adequate blood counts and organ function

Exclusion Criteria:

- Pregnant or lactating women

- Laboratory Parameters as outlined in the protocol

- LV ejection fraction lower than normal as assessed by echocardiogram or MUGA scan

- DLCO less than 60% as measured by pulmonary function tests

- Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for over one year

- Current or recent (within 4 weeks of the first infusion of this study) participation in an experimental drug study

- Life expectancy of less than 12 weeks

- Inability to comply with study procedures

- Inability to give informed consent

- Inadequately controlled hypertension

- Any prior history of hypertensive crisis or hypertensive encephalopathy

- NYHA Grade II or greater congestive heart failure

- History of myocardial infarction or unstable angina within 6 months prior to study enrollment

- History of stroke or transient ischemic attack within 6 months prior to study enrollment

- Known CNS involvement of Hodgkin lymphoma

- Significant vascular disease

- Symptomatic peripheral vascular disease

- Evidence of bleeding diatheses or coagulopathy

- Use of daily anticoagulant medications including warfarin, heparins, or aspirin >325mg daily

- Major surgical procedure or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study

- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days of study enrollment

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment

- Serious, non-healing wound, ulcer, or bone fracture

- Proteinuria at screening

- Known hypersensitivity to any component of bevacizumab

- Pregnant or lactating

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Avastin
Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Failure-free Survival Failure-free survival: the absence of relapse, non-relapse mortality or addition of another systemic therapy 2 years and median follow-up of 18 months
Secondary Overall Response Rate Using the Modified Cheson Criteria Overall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (<=1.5cm in greatest diameter) PR = >=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT 2 years
Secondary Progression-free Survival Progression-free survival: a patient lives with the disease but it does not get worse. 2 years and medium follow-up of 18 months
Secondary Overall Survival Overall survival: patients are still alive. 2 years
Secondary Safety Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening) 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Completed NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Recruiting NCT05019976 - Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma N/A
Active, not recruiting NCT03617666 - Avelumab in the Frontline Treatment of Advanced Classical Hodgkin Lymphoma - a Window Study Phase 2
Completed NCT04666025 - SARS-CoV-2 Donor-Recipient Immunity Transfer
Recruiting NCT02507479 - Thiotepa-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies Phase 2
Active, not recruiting NCT02191930 - Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma Phase 2
Completed NCT01943682 - Safety Study of CPX-351 in Children With Relapsed Leukemia or Lymphoma Phase 1
Completed NCT01393106 - Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma Phase 2
Terminated NCT00992030 - R-ABVD vs ABVD-RT in Early Stage Hodgkin's Lymphoma Phase 3
Unknown status NCT00598624 - Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) Phase 2
Completed NCT03242902 - To Decrease Fatigue With Light Therapy Phase 3
Active, not recruiting NCT05205512 - Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial N/A
Recruiting NCT03681561 - Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma Phase 1/Phase 2
Recruiting NCT03250962 - SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma Phase 2
Recruiting NCT04510610 - Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Phase 2/Phase 3
Completed NCT06295211 - Brentuximab Vedotin Combined With Bendamustine Supercharge, a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma: Long-term Results of a Retrospective Monocenter Study.
Active, not recruiting NCT02256137 - A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer
Completed NCT02432235 - Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma Phase 1
Completed NCT02572167 - A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma Phase 1/Phase 2