Status:
UNKNOWN
Comparative Study of Individualized Sensitivity-Directed Chemotherapy Versus DTIC
Lead Sponsor:
University of Wuerzburg
Collaborating Sponsors:
Hiege-Stiftung gegen Hautkrebs
medac GmbH
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This phase III trial is aimed to investigate the efficacy of an individualized, sensitivity-directed combination chemotherapy in comparison to the standard regimen DTIC. Two question are aimed to be ...
Detailed Description
Melanoma is a cutaneous neoplasm known for its high aggressiveness, its early dissemination of metastases, and its poor prognosis once metastasized. Chemotherapy with dacarbacine (DTIC) is widely acce...
Eligibility Criteria
Inclusion
- Histologically confirmed melanoma of the skin, mucosa, or unknown primary, diagnosed with surgically unresectable distant metastases (stage IV according to AJCC).
- At least one measurable target lesion according to RECIST, assessed by CT or MRI (tumor assessment by X-ray or ultrasonography only is not allowed).
- Access to a biopsy of \~1 cm3 from at least one metastatic lesion for in vitro chemosensitivity testing. Cell suspensions from malignant effusions are also eligible.
- No prior chemotherapy in stage IV (adjuvant chemotherapy in stage III allowed; one prior regimen of immunotherapy or targeted therapy in stage IV allowed).
- No evidence of brain/CNS metastases. Former history of brain/CNS metastases, which have been treated successfully, and are no longer visible in CT/MRI is allowed.
- Last complete tumor assessment (CT or MRI of thorax, abdomen and brain) not older than 14 days prior to registration, and not older than 5 weeks prior to onset of study treatment.
- ECOG/WHO performance index of 0 or 1.
- Patients must have stopped any kind of previous antineoplastic therapy for at least 2 weeks prior to registration, and at least 4 weeks prior to treatment onset.
- Patients must not have concurrent or recent malignancies except for surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin. Patients with previous malignancies, which have been treated with a subsequent disease-free interval of at least 5 years, are eligible.
- Patient age ≥ 18 years.
- Adequate hematological, renal and liver function as defined by the following laboratory values performed within 14 days prior to randomisation:
- absolute neutrophil count (ANC) ≥ 1.5 x 109/l
- platelet count ≥ 100 x 109/l
- hemoglobin ≥ 9 g/dl
- urea and serum creatinine ≤ 2 times upper normal limit (UNL)
- total and direct serum bilirubin ≤ 2 times UNL
- GOT or GPT ≤ 2.5 times UNL; ≤ 5 times UNL is allowed in case of liver metastasis
- alkaline phosphatase \< 2.5 times UNL
- Female patients should not be pregnant or nursing. Women of childbearing potential should be using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner). For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.
- Male patients should use an effective method of contraception.
- Before registration, written informed consent must be given according to GCP guidelines and national/local regulations. Patients must be willing and giving informed consent to participation in the trial.
Exclusion
- All metastatic lesions are surgically resectable.
- Prior chemotherapy in stage IV (adjuvant chemotherapy in stage III allowed; one prior regimen of immunotherapy or targeted therapy in stage IV allowed).
- Primary melanoma of the uvea / choroidea.
- Evidence of brain/CNS metastases. Former history of brain/CNS metastases, which have been treated successfully, and are no longer visible in CT/MRI is allowed.
- ECOG/WHO performance index of 2 or higher
- Concurrent or recent malignancies except for surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin. Patients with previous malignancies, which have been treated with a subsequent disease-free interval of at least 5 years, are eligible.
- Any severe or uncontrolled hematological, renal or liver dysfunction as defined by the laboratory values given in Inclusion Criteria.
- Any clinically uncontrolled infectious disease including HIV positivity or AIDS-related illness.
- Any female patients who are pregnant or nursing.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration for the trial.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00779714
Start Date
October 1 2008
End Date
April 1 2013
Last Update
October 24 2008
Active Locations (23)
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1
Dept of Dermatology, University of Aachen
Aachen, Germany, 52074
2
Dept of Dermatology, University of Berlin Charite
Berlin, Germany, 10117
3
Dept of Dermatology, University of Bochum
Bochum, Germany, 44791
4
Medizinisches Zentrum Bonn Friedensplatz
Bonn, Germany, 53111