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Phase Ib/IIa Study of SLIT Cisplatin by Inhalation in the Treatment of Patients Wtih Relapsed/Progressive Osteosarcoma Metastatic to the Lung

Phase 1/Phase 2
13 Years
50 Years
Not Enrolling

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Trial Information

Phase Ib/IIa Study of SLIT Cisplatin by Inhalation in the Treatment of Patients Wtih Relapsed/Progressive Osteosarcoma Metastatic to the Lung

Osteosarcoma, preferentially metastasizes to the lung. The presence of lung metastases has a
major impact on the prognosis of patients with osteosarcoma. Upon surgical removal of the
tumor in the lung, new pulmonary metastases often recur within months suggesting
micro-metastatic disease resistant to systemic chemotherapy.

The Sustained release lipid inhalation targeting (SLIT) technology offers the potential
ability to attain a prolonged therapeutic effect of cisplatin in the lung by sustained
release. The ability to give SLIT Cisplatin by inhalation directly to the lung permits high
drug levels at the site of disease with low systemic exposure.

Patients will receive SLIT Cisplatin by inhalation for a 14-day treatment cycle in this
phase Ib/IIa, two-center, open-label, study designed to characterize the maximum tolerated
dose. Clinical efficacy endpoints will be included and compared to historical controls, in
addition to pharmacokinetics characterization. Efficacy will be evaluated after at least 2
cycles of therapy. Safety data, including laboratory parameters and adverse events will be
collected to determine the qualitative and quantitative toxicity, and reversibility of
toxicity, of SLIT Cisplatin. Pulmonary function tests will be performed at baseline, prior
to each course and at off-study.

Inclusion Criteria:

- Histologically proven, Progressive or recurrent high grade osteosarcoma metastatic to
the lung

- Measureable pulmonary metastases.

- Less than grade 3 neuropathies, insignificant decreases in cardiac or auditory

- ECOG performance status of 0, 1 or 2

- FEV1 of 50% or greater of predicted value

- FEV1/FVC ratio of 65% or greater

- Serum creatinine of
- Total bilirubin
- ANC of >/= 1,000/mm3 and platelet count of >= 100,000/mm3

Exclusion Criteria:

- Grade 3 or higher neuropathy

- Concurrent systemic chemotherapy

- Pulmonary atelectasis

- Significant reactive airway disease

- Concurrent serious infections

- Unstable or serious concurrent medical condition

- Recent major surgery

- Significant pulmonary fibrosis

- Major ventilatory distribution abnormalities

- Osteosarcoma secondary to radiation or premalignant conditions

- History of prior malignancy

- Low grade osteosarcoma, parosteal or periosteal sarcoma

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Principal Investigator

Renu Gupta, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Transave Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

January 2005

Completion Date:

March 2008

Related Keywords:

  • Osteosarcoma
  • Osteosarcoma
  • relapsed
  • progressive
  • metastatic
  • lung
  • Osteosarcoma



Memorial Sloan Kettering Cancer Center New York, New York  10021
The Albert Einstein College of Medicine Montefiore Medical Center New York, New York  10467