Status:
COMPLETED
IMP321 Phase 1 Trial in Metastatic Renal Cell Carcinoma (MRCC)
Lead Sponsor:
Immutep S.A.S.
Collaborating Sponsors:
Umanis
Conditions:
Stage IV Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Single-center, open label, non-randomized, fixed dose-escalation, phase 1 study, performed in ambulatory and day-hospital setting
Detailed Description
This is a single-center, single-arm, open label, non-randomized, fixed dose-escalation, phase 1 study, performed in ambulatory and day-hospital setting. After a screening period, patients will enter a...
Eligibility Criteria
Inclusion
- Patient with metastatic renal clear cell (MRCC) adenocarcinoma, histologically proven by biopsy of the primary tumor and/or a metastasis. Prior nephrectomy is not required. The patient will be included in the study only if an efficacious cancer treatment can not be proposed.
- Patient to whom the currently available anticancer treatments are contra-indicated.
- Male or female 18 years or above. NB: Women must be either post-menopausal, rendered surgically sterile or practicing a reliable method of contraception (hormonal, intrauterine device or barrier). Pregnant women are excluded from this study.
- ECOG performance status 0-1.
- Expected survival longer than three months.
- Total white cell count ≥ 3.109/L.
- Platelet count ≥ 100.109/L.
- Hemoglobin \> 9 g/dL or \> 5.58 mmol/L.
- Serum creatinine \< 160 µmol/L.
- Total bilirubin \< 20 mmol/L, except for familial cholemia (Gilbert's disease)
- Serum ASAT and ALAT \< 3 times the upper limit of normal or \< 5 times upper limit of normal if liver metastases are present.
- Able to give written informed consent and to comply with the protocol.
Exclusion
- Pregnancy, lactation or lack of effective contraception in fertile women of childbearing potential.
- Serious intercurrent infection within the 30 days prior to first administration.
- Known clinically active autoimmune disease.
- Known B or C active hepatitis.
- Known HIV positivity.
- Life threatening illness unrelated to cancer.
- Known cerebral metastases.
- Previous malignancies within the last two years other than successfully treated squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated with cone biopsy.
- Previous history of major psychiatric disorder requiring hospitalization or any current psychiatric disorder that would impede the patient's ability to provide informed consent or to comply with the protocol.
- Corticosteroids unless used as substitutive therapy.
- Past history of severe allergic episodes and/or Quincke edema.
- Past or present history of any organic disorder likely to modify absorption, distribution or elimination of the study drug.
- Alcohol or substance abuse disorder.
- IL-2 therapy or any other investigational agent within 30 days of first administration.
- Chemotherapy or radiotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to first administration of the study drug or lack of recovery from adverse events (to grade 1 or less toxicity according to CTCAE 3.0) due to agents administered more than 4 weeks earlier. Exception is made regarding the x-ray treatment for painful bone metastases.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00351949
Start Date
September 1 2005
End Date
October 1 2008
Last Update
January 7 2010
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94805