Combination Chemotherapy in Treating Younger Patients With Hodgkin Lymphoma

NCT00666484 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000593560UCL/07/0052007-003080-45EU-20844
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known which regimen of combination chemotherapy is more effective for Hodgkin lymphoma. PURPOSE: This phase II trial is studying the side effects of three different regimens of combination chemotherapy and to see how well they work in treating younger patients with Hodgkin lymphoma.

Conditions

Lymphoma; Neurotoxicity

Keywords

neurotoxicity; stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; adult lymphocyte depletion Hodgkin lymphoma; adult lymphocyte predominant Hodgkin lymphoma; adult mixed cellularity Hodgkin lymphoma; adult nodular sclerosis Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Neurotoxicity due to the intensive use of Vinca alkaloids

  End of treatment

Secondary Outcomes (4)

• Response rate

  End of treatment

• Disease-free survival

  Not specified in protocol

• Overall survival

  Not specified in protocol

• Gonadal toxicity

  Not specified in protocol

Study Arms (3)

Treatment Group 1: stages 1A, 1B, 2A: OEPA x 2

EXPERIMENTAL

OEPA (28day cycle): Vincristine 1.5mg/m\^2 iv d1,d8,d15 (capped at 2mg/dose) Etoposide 125mg/m\^2 iv d1-5 Prednisolone 60mg/m\^2 po d1-15 Adriamycin 40mg/m\^2 iv d1 and 15

Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: prednisolone; Drug: vincristine sulfate; Radiation: radiation therapy

Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2

EXPERIMENTAL

OEPA (28 day cycle) Vincristine 1.5mg/m\^2 iv d1,d8,d15 (capped at 2mg/dose) Etoposide 125mg/m\^2 iv d1-5 Prednisolone 60mg/m\^2 po d1-15 Adriamycin 40mg/m\^2 iv d1 and 15 COPP (28 day cycle) Cyclophosphamide 500mg/m\^2 iv d1 and 8 Vincristine 1.5mg/m\^2 iv d1,8 (capped 2mg/dose) Procarbazine 100mg/m\^2 po d1-15\* Prednisolone 40mg/m\^2 po d1-15

Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: prednisolone; Drug: procarbazine hydrochloride; Drug: vincristine sulfate; Radiation: radiation therapy

Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4

EXPERIMENTAL

OEPA (28 day cycle) Vincristine 1.5mg/m\^2 iv d1,d8,d15 (capped at 2mg/dose) Etoposide 125mg/m\^2 iv d1-5 Prednisolone 60mg/m\^2 po d1-15 Adriamycin 40mg/m\^2 iv d1 and 15 COPP (28 day cycle) Cyclophosphamide 500mg/m\^2 iv d1 and 8 Vincristine 1.5mg/m\^2 iv d1,8 (capped 2mg/dose) Procarbazine 100mg/m\^2 po d1-15\* Prednisolone 40mg/m\^2 po d1-15

Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: prednisolone; Drug: procarbazine hydrochloride; Drug: vincristine sulfate; Radiation: radiation therapy

Interventions

cyclophosphamide DRUG

Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2; Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4

doxorubicin hydrochloride DRUG

Treatment Group 1: stages 1A, 1B, 2A: OEPA x 2; Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2; Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4

etoposide DRUG

Treatment Group 1: stages 1A, 1B, 2A: OEPA x 2; Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2; Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4

prednisolone DRUG

Treatment Group 1: stages 1A, 1B, 2A: OEPA x 2; Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2; Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4

procarbazine hydrochloride DRUG

Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2; Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4

vincristine sulfate DRUG

Treatment Group 1: stages 1A, 1B, 2A: OEPA x 2; Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2; Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4

radiation therapy RADIATION

Treatment Group 1: stages 1A, 1B, 2A: OEPA x 2; Treatment Group 2: stages 2AE, 2B, 3A: OEPA x 2 + COPP x 2; Treatment Group 3: stages 2BE, 3AE, 3B, 4: OEPAx2 + COPPx4

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Biopsy proven de-novo classical Hodgkin lymphoma * Any stage disease * No nodular lymphocyte-predominant Hodgkin lymphoma PATIENT CHARACTERISTICS: * No known or suspected HIV infection * No pre-existing neurological disorder * No serious comorbidity which may prevent administration of study treatment * No other previous malignancy * Not pregnant or nursing * Fertile patients must use effective contraception during and for up to 1 year after completion of study treatment * Creatinine ≤ 1.5 times upper limit of normal (ULN) unless due to the lymphoma * ALT/AST ≤ 1.5 times ULN unless due to the lymphoma * Bilirubin ≤ 2 times ULN unless due to the lymphoma PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy * No prior organ transplant

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University College, London: lead

Study Sites (5)

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

University College Hospital - London

London, England, NW1 2PG, United Kingdom

Location

King's College Hospital

London, England, SE5 9RS, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma; Neurotoxicity Syndromes; Hodgkin Disease

Interventions

Cyclophosphamide; Doxorubicin; Etoposide; Prednisolone; Procarbazine; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Therapeutics

Study Officials

• Kirit Ardeshna

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 25, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

GB (5)