Glioblastoma Multiforme

Study drug Pazopanib will be administered once tumoral evaluation has been performed and after Stupp Protocol (TMZ + Radiation) realisation.

Pazopanib

Centre Antoine Lacassagne

Phase I/II Study of Pazopanib+ Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

A Phase I/II Study of Pazopanib in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme After Surgery and RT-CT

To evaluate the Recommended Phase 2 Dose (RP2D) of pazopanib in oral route in addition to the maintenance phase of the Stupp protocol, regarding the toxicities that should not be more than 33 %

To define the overall tolerance of pazopanib associated with TMZ during the maintenance phase of the "Stupp protocol" regarding biological toxicities, blood pressure and hemorragic events

To assess the antitumor activity of the adjunction of daily dose of pazopanib to the maintenance phase of the Stupp protocol according to the Revised Assessment in Neuro-Oncology (RANO) criteria (response rate) and the median duration of response.

To determine the median Progression-Free-Survival (mPFS), the PFS rate at 12 (PFS-12) months.

To determine the median Overall Survival (mOS), the OS rate at 6 (OS-6) and 12 (OS-12) months.

To determine the pharmacokinetics (PK) profile of pazopanib when given in combination with TMZ.

To determine the pharmacokinetics (PK) profile of TMZ when given in combination with pazopanib.

GlaxoSmithKline

KSHV Inflammatory Cytokine Syndrome (KICS)

KSHV

HHV-8

Zidovudine 600 mg will be administered orally 4 times a day or i.v. at 300 mg every 6 hours for 14 days for cycle 1 and for 7 days (up to additional 7 days if ongoing symptoms) for following cycles.

Zidovudine

Liposomal doxorubicin (20 mg/m2) will be administered i.v. over 1 hour at day 1 of each cycle

Liposomal Doxorubicin

Valganciclovir (900mg) will be administered orally twice/day or Ganciclovir (5 mg/kg) will be administered i.v. over 1 hour for 14 days for cycle 1 and for 7 days (up to additional 7 days if ongoing symptoms) for following cycles.

Valganiclovir

Rituximab (375 mg/m2) will be admnistered i.v. at 50 mg/hr up to 100 mg/hr at day 1 of the first cycle and at 100mg/hr up to 400 mg
/hr at day 1 of following cycles.

Rituximab

Standard Therapies

National Institutes of Health Clinical Center, 9000 Rockville Pike

History of the KSHV Inflammatory Cytokine Syndrome (KICS)

Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS) Incorporating Pilot Evaluation of KSHV Targeted Therapies

Description of the natural history of KICS, including the spectrum of clinical, laboratory and radiographic abnormalities seen in affected patients

Clinical response rate with institution of each specific therapy (high dose zidovudine/valganciclovir or rituximab/liposomal doxorubicin

National Cancer Institute (NCI)

HIV Infections

Giant Lymph Node Hyperplasia

Rituximab in the Treatment of HIV Associated Multicentric Castleman Disease Dependent on Chemotherapy

Multicenter, Phase II Trial Assessing the Efficacy of Rituximab in HIV Infected Patients With Multicentric Castleman Disease Dependent on Chemotherapy (ANRS 117 Study, CastlemaB)

sarcoma/ödem

Phase I/II Study of Pazopanib+ Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

History of the KSHV Inflammatory Cytokine Syndrome (KICS)

Rituximab in the Treatment of HIV Associated Multicentric Castleman Disease Dependent on Chemotherapy

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