Fusilev (Levoleucovorin Calcium) - Summary

FUSILEV SUMMARY

Fusilev for injection contains levoleucovorin calcium, which is one of several active, chemically reduced derivatives of folic acid. It is useful as antidote to the inhibition of dihydrofolate reductase by methotrexate.

• Fusilev™ is a folate analog.
• Fusilev rescue is indicated after high-dose methotrexate therapy in osteosarcoma.
• Fusilev is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.

NEWS HIGHLIGHTS

Clinical Trials Related to Fusilev (Levoleucovorin)

Hepatic Arterial Infusion Oxaliplatin + 5FU, Leucovorin, and Bevacizumab +/- Cetuximab [Recruiting]
The goal of this clinical research study is to find the best combination of oxaliplatin, bevacizumab, 5-fluorouracil, leucovorin, and cetuximab that can be given to patients with advanced cancer that has spread to the liver. Different combinations of these drugs will be used, and the safety of all drug combinations will also be studied.

Study of Irinotecan Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer [Recruiting]
Open-label phase 1b trial. Study treatment will be administered in 3 week cycles.

There are two distinct parts in this study:

- Part 1: Dose escalation from IMO-2055

- Part 2: Once a recommended phase 2 dose is found additional tolerability and

pharmacodynamics will be explored

Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients [Recruiting]
Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard weight based ribavirin (investigational treatment arm) or placebo in combination with ribavirin (RBV). Each cohort of 15 patients will be randomized 4: 1 to receive the investigational treatment arm (12 patients) or placebo and RBV arm (3 patients).

Safety of Adding IMO-2055 to Erlotinib + Bevacizumab in 2nd Line Treatment for Patients With NSCLC [Recruiting]
To evaluate the safety of the proposed Phase II dosage of the investigational drug IMO 2055 when combined with erlotinib and bevacizumab in patients with previously treated advanced NSCLC.

Study of MBP-426 in Patients With Second Line Gastric, Gastroesophageal, or Esophageal Adenocarcinoma [Recruiting]
This will be a Phase Ib/II, open-label, non-randomized, single arm study of MBP-426. MBP-426 will be administered every 21 days as an intravenous (IV) infusion at a starting dose of 226 mg/m2, in combination with leucovorin (folinic acid or FA) and 5 fluorouracil (FU). Following MBP-426 administration, leucovorin (400 mg/m2) will be administered IV with an IV bolus of 400 mg/m2 fluorouracil (on the same day as MBP 426), followed by 2400 mg/m2 fluorouracil continuous IV (CIV) infusion over 46 hours. Patients will be premedicated 15 minutes prior to MBP-426 infusion with 10 mg dexamethasone (IV), 8 mg Zofran®, and 25 mg Benadryl®.

In the Phase Ib portion of this study, the first cohort of patients will receive MBP-426 at a dose of 226 mg/m2. Subsequent patients will be treated at doses in accordance with the table below. The dose for the Phase II study will be determined based on the toxicity seen in the Phase Ib patients.

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