PVAG-14 Pilot for Intermediate Stages Hodgkin Lymphoma
Overview[ - collapse ][ - ]
| Purpose | A randomized phase II study of prednisone, vinblastine, doxorubicin, and gemcitabine in patients with intermediate stage Hodgkin's lymphoma |
|---|---|
| Condition | Hodgkin Lymphoma |
| Intervention | Drug: prednisone Drug: vinblastine Drug: doxorubicin Drug: gemcitabine |
| Phase | Phase 2 |
| Sponsor | University of Cologne |
| Responsible Party | University of Cologne |
| ClinicalTrials.gov Identifier | NCT00512980 |
| First Received | August 7, 2007 |
| Last Updated | May 12, 2011 |
| Last verified | May 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 7, 2007 |
|---|---|
| Last Updated Date | May 12, 2011 |
| Start Date | August 2008 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Not Provided |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | PVAG-14 Pilot for Intermediate Stages Hodgkin Lymphoma |
|---|---|
| Official Title | A Randomized Phase II Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Patients With Intermediate Stage Hodgkin's Lymphoma |
| Brief Summary | A randomized phase II study of prednisone, vinblastine, doxorubicin, and gemcitabine in patients with intermediate stage Hodgkin's lymphoma |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment |
| Condition | Hodgkin Lymphoma |
| Intervention | Drug: prednisone Drug: vinblastine Drug: doxorubicin Drug: gemcitabine |
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | Not Provided |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | June 2011 |
| Eligibility Criteria | Inclusion Criteria: 1. Histologically confirmed diagnosis of Hodgkin's lymphoma 2. Stage - Clinical Stage IA, IB, IIA with at least one of the risk factors a-d given below - Clinical Stage IIB with one or both risk factors c-d given below risk factors: - Large mediastinal mass (≥ 1/3 of the greatest thorax diameter as measured by chest x-ray) - Extranodal involvement - High erythrocyte sedimentation rate (≥ 50 mm/h in patients without B-symptoms, ≥ 30 mm/h in patients with B-symptoms) - Three or more involved lymph node areas 3. No prior therapy for Hodgkin's lymphoma (exception: pre-phase treatment with corticosteroids and vinca-alkaloids for a maximum of seven days may not preclude trial participation if clinically indicated and all staging examinations have been performed; all forms of prior radiotherapy preclude trial participation) 4. Age: 18-60 years 5. Signed informed consent with understanding of the study procedures and the investigational nature of the study 6. Patient agrees that personal data and tissue samples are provided to the GHSG (protection of privacy as defined by law will be ensured) 7. Life expectancy > 3 months according to investigator judgement. Exclusion Criteria: 1. Incomplete diagnosis of stage of disease 2. Prior or concurrent disease which prevents treatment according to protocol In particular the following contraindications: - Chronic obstructive pulmonary disease with global insufficiency - Symptomatic coronary heart disease - Cardiomyopathy or cardiac insufficiency (NYHA value of EF < 50% or FS < 25%) - Serious uncontrolled hypertension - Uncontrollable infection - Leucocyte concentration < 3.000/mm3 or thrombocyte concentration < 100.000/mm3 - Creatinin clearance < 60 ml/min - Bilirubin > 2 mg/dl or GPT > 100 U/l or GOT > 100 U/I (exception: elevated values of Hodgkin`s disease liver involvement) - HIV-Infection according to HIV test - Chronic or acute Hepatitis 3. HD as composite lymphoma 4. Prior chemotherapy or radiation 5. Malignant disease within the last 5 years (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1) 6. Pregnancy, lactation, positive pregnancy test 7. Refusal to use effective contraception 8. WHO performance index > 2 9. Long-term ingestion of corticosteroids (e.g. for chronic polyarthritis) or antineoplastic drugs (e.g. methotrexate) 10. Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly 11. Non compliance: Refusal of blood products during treatment, epilepsy, drug dependency, change of residence abroad, prior cerebral injury or similar circumstances which appear to make protocol treatment or long-term follow-up impossible 12. Antiepileptic treatment 13. General intolerance of any protocol medication 14. Any contraindication for study medication according to the summaries of product information 15. Simultaneous participation in another clinical 16. Institutionalization by law 17. Relation of dependence with the sponsor`s representative / trialist |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Germany |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00512980 |
|---|---|
| Other Study ID Numbers | PVAG-14 pilot |
| Has Data Monitoring Committee | No |
| Information Provided By | University of Cologne |
| Study Sponsor | University of Cologne |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Andreas Engert, Prof University of Cologne |
| Verification Date | May 2011 |
Locations[ + expand ][ + ]
| University of Cologne | Cologne, Germany |
|---|