A Novel Single Arm Phase II Study for Relapsed Germ Cell Tumours With Poor ... | Recruiting
A Novel Single Arm Phase II Study f... | Recruiting
A Novel Single Arm Phase II Study for Relapsed Germ Cell Tumours With Poor Prognosis
GAMMA

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Medical Conditions
  • Germ Cell Tumour
Primary Contact Details
GAMMA Coordinator
+44 (0)20 7882 8762
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT01782339
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
The treatment of germ cell tumours is considered to be one of the major successes in the area of cytotoxic chemotherapy. Even in patients who relapse after first line therapy, a durable remission rate of between 25% and 60% has been seen using further chemotherapy. In 1999, researchers at St Bartholomew's Hospital developed the GAMEC protocol (combination chemotherapy with filgrastim, actinomycin D, methotrexate, etoposide, cisplatin). Results from this study showed that 50% of patients with relapsed testicular cancer could be cured using this treatment. When we reviewed the individual patients it was clear that older patients (>35yrs) or patients with a raised Lactate Dehydrogenase (a blood test that monitors cancer activity), did not do as well. In addition, patients whose original tumour started in their chest (mediastinal germ cell tumour) have tended to do badly if they relapse. We have been developing a study for patients who fulfil at least one of these criteria. The GAMIO study (filgrastim, actinomycin D, methotrexate, irinotecan, oxaliplatin) has recently closed due to problems with high levels of toxicity from the irinotecan. GAMMA is a new study that will use paclitaxel instead of irinotecan and oxaliplatin instead of cisplatin. We expect that this treatment with oxaliplatin will be less damaging to the kidneys than cisplatin. Both oxaliplatin and paclitaxel and oxaliplatin and irinotecan have similar activity in relapsed patients in the phase II setting. We hope to improve on our previous results with this substitution and see if this will lead to an improvement in the cure rate of relapsed germ cell tumours with poor prognosis and reduce the side effects compared to our standard treatment. In addition, we do not expect any hearing damage and the treatment requires a shorter hospital stay.
Research Details
  • Patients will receive a 4 drug combination chemotherapy in hospital over two nights. On the third day, the patient will receive an injection of pegfilgrastim. This stimulates the bone marrow to produce white blood cells and shortens the period of risk of serious infection. The treatment will be repeated every three weeks. This constitutes one cycle of treatment. We aim to give the patient four cycles of treatment over a total of twelve weeks.

    Before each cycle, the following will be conducted - physical examination, full blood count, urea + electrolytes, liver function tests, LDH, αFP, βHCG.

    Patients will have a FDG PET-CT scan at baseline, prior to cycle 2(approximately 1521 days after chemotherapy starts)and within 28 days of the last treatment, only if clinically indicated. On each cycle, serum creatinine should be measured 24 hours after the start of the methotrexate to exclude renal failure due to methotrexate.

    The following will be conducted at the end of treatment physical examination, full blood count, urea + electrolytes, liver function tests, LDH, αFP, βHCG. The patients will be monitored during chemotherapy and then monthly in the first year and two monthly in the second year.

    An interim analysis will be performed after 15 patients have completed treatment. If less than 9 responses are observed in this group, the study will be terminated. The final analysis will be performed after 43 patients have recruited, completed treatment and been followed for 24 months.
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Combination Chemotherapy

Study Arm Groups : Combination Chemotherapy

Intervention Type
See Interventions above
Primary Outcome Measures
    Objective response rate; 2 years
Secondary Outcome Measures
    Progression Free Survival; 2 years; Overall Survival; 2 years; Toxicity Level; 2 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
16 Years - 65 Years
Who Can Participate
Patients
Number of Participants
43
Participant Inclusion Criteria
    Inclusion Criteria:

    - Germ Cell Tumour (GCT)

    - Relapsed or progression on or following platinum-based chemotherapy (rising tumour markers or progressive disease on PET CT Scan prior to entering study)

    - Neutrophil count >1.0x109/l

    - Platelets >70x109/l

    - Haemoglobin >100g/l (may be transfused)

    - Glomerular filtration rate >40ml/min (determined by EDTA clearance or calculated creatinine clearance using the Cockcroft - Gault equation if unable to perform EDTA clearance)

    - Males and females aged 16-65 years

    a) Male patients must have IGCCCG2 prognostic score, low to very high

    - Patients must be sterile or agree to use adequate contraception during the period of therapy

    - ECOG Performance status 0-3

    - Able and willing to give written informed consent and comply with the protocol study procedures.

    Exclusion Criteria:

    - Other malignancy except basal cell carcinoma

    - Significant co-morbidity likely to make delivery of this treatment unsafe

    - Currently enrolled in any other investigational drug study

    - Previous chemotherapy with oxaliplatin, methotrexate or Actinomycin D

    - Patients who have peripheral neuropathy with functional impairment
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
EC1A 7BE
Trial Contact(s)
Primary Trial Contact
GAMMA Coordinator
+44 (0)20 7882 8762
Other Trial Contacts
Hayley Cartwright
+44 (0)20 7882 8196
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Novel Single Arm Phase II Study for Relapsed Germ Cell Tumours With Poor Prognosis
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
007755
Sponsor(s)
Barts & The London NHS Trust
Key Dates

Recruitment Start Date

Jul 2012

Recruitment End Date

Jan 2021

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

31 Jan 2013

Date updated in source

30 Aug 2017