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LymphomaPhase 2NCT00666484

Combination Chemotherapy in Treating Younger Patients With Hodgkin Lymphoma

A Phase 2 study testing cyclophosphamide, doxorubicin hydrochloride and etoposide in people with Lymphoma and Neurotoxicity, run by University College, London at 5 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 years
Conditions the study is for
Lymphoma, Neurotoxicity
What is being tested?
cyclophosphamide, doxorubicin hydrochloride and etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
5 sitesUnited Kingdom
Study dates
Mar 2008to Sep 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United Kingdom5 sites

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

  • University College Hospital - London

    London, England, NW1 2PG

  • King's College Hospital

    London, England, SE5 9RS

  • Northern Centre for Cancer Treatment at Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

Other trials in United Kingdom

About this study

Official title: Phase II Study Evaluating the Toxicity and Efficacy of a Modified German Paediatric Hodgkin's Lymphoma Protocol (HD95) in Young Adults (Aged 18-30 Years) With Hodgkin's Lymphoma

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.

Read the detailed description

OBJECTIVES:

Primary

  • To establish neurotoxicity of OEPA+COPP chemotherapy in young adults.

Secondary

  • To determine response rates in patients treated with this regimen.
  • To determine disease-free survival of patients treated with this regimen.
  • To determine overall survival of patients treated with this regimen.
  • To determine gonadal toxicity in patients treated with this regimen.

OUTLINE: Patients are assigned to treatment group according to stage.

  • Group 1 (patients with stage 1A, 1B, or 2A disease): Patients receive OEPA chemotherapy comprising vincristine IV on days 1, 8, and 15; oral prednisolone on days 1-15; etoposide IV on days 1-5; and doxorubicin hydrochloride IV on days 1 and 15. Courses repeat every 28 days for 2 courses. Patients achieving a partial response also undergo radiotherapy after completion of chemotherapy; patients achieving a complete response do not undergo radiotherapy.
  • Group 2 (patients with stage 2AE, 2B, or 3A disease): Patients receive 2 courses of OEPA chemotherapy as in group 1. Patients then receive COPP chemotherapy comprising cyclophosphamide IV on days 1 and 8; vincristine IV on days 1 and 8; oral procarbazine hydrochloride on days 1-15; and oral prednisolone on days 1-15. Courses repeat every 28 days for 2 courses. Patients also undergo radiotherapy after completion of chemotherapy.
  • Group 3 (patients with stage 2BE, 3AE, 3BE, 3B, 4A, or 4B disease): Patients receive 2 courses of OEPA chemotherapy as in group 1. Patients then receive COPP chemotherapy as in group 2. Treatment with COPP chemotherapy repeats every 28 days for 4 courses. Patients also undergo radiotherapy after completion of chemotherapy.

In all groups, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Being tested
cyclophosphamide, doxorubicin hydrochloride, etoposide, prednisolone, procarbazine hydrochloride
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
Medical subject headings
Lymphoma, Neurotoxicity Syndromes, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00666484
Study groupRoleWhat they receive
Treatment Group 1: stages 1A, 1B, 2A: OEPA x 2ExperimentalOEPA (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
Receives: 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 2ExperimentalOEPA (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
Receives: 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 + COPPx4ExperimentalOEPA (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
Receives: Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: prednisolone; Drug: procarbazine hydrochloride; Drug: vincristine sulfate; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurotoxicity due to the intensive use of Vinca alkaloids

    Measured: End of treatment

Secondary outcomes (4)

  1. Response rate

    Measured: End of treatment

  2. Disease-free survival

    Measured: Not specified in protocol

  3. Overall survival

    Measured: Not specified in protocol

  4. Gonadal toxicity

    Measured: Not specified in protocol

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00666484
Sponsor's protocol ID
CDR0000593560
Other IDs
UCL/07/005, 2007-003080-45, EU-20844
Status last verified
Dec 2014
First submitted
24 Apr 2008
Last updated
4 Dec 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cyclophosphamide, doxorubicin hydrochloride and etoposide in people with Lymphoma and Neurotoxicity, run by University College, London at 5 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurotoxicity due to the intensive use of Vinca alkaloids (time frame: End of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00666484.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.

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