Call for Letters of Intent for studies that will improve outcomes for recurrent osteosarcoma patients
The Osteosarcoma Institute (OSI) was established in November 2017 to develop a comprehensive strategy that will lead to major improvement in the life expectancy of patients with relapsed and metastatic osteosarcoma. To further this goal, the OSI is seeking Letters of Intent (LOI) for grant proposals to conduct clinical, correlative, and translational studies.
GRANT CATEGORIES AND APPLICATION GUIDANCE
Clinical trials (up to $800,000) – The primary objective of clinical studies should be to improve EFS at 4 months, beyond historical rates known to be in the range of 12%. The proposed study may be carried out in a single institution, a clinical trial consortium, or through an existing clinical trial infrastructure. OSI will not prioritize the launch of new infrastructures to conduct clinical trials. Please provide specific timetables for protocol development, regulatory approvals, industry agreements, IRB approvals, activation, accrual, and reporting. We will consider the proposer’s prior history of efficiently entering agreements, opening trials, and meeting accrual expectations for studies of relapsed osteosarcoma patients, with the expectation that results will be available within a 3-year time frame or less. Other desirable characteristics for proposals include:
- Answering an important question
- Strong preclinical rationale
- Rigorous trial design and correlative endpoints to allow for productive failure
- Budget reasonableness (per patient and total)
- Commitment of concurrent financial support of the trial (e.g., direct institutional support, industry and/or philanthropic support, securing drug, etc.)
Correlative studies ($250,000 – $500,000 over two years) – Correlative studies should seek to generate data in support of such future clinical studies seeking to improve event free survival of recurrent and metastatic osteosarcoma patients. Proposals may include hypothesis testing and/or exploratory, hypothesis generating elements, and should include/prioritize the following:
- The generation of new correlative biology data that will improve our understanding of osteosarcoma metastases, optimize an associated clinical trial in recurrent and metastatic osteosarcoma patients, and/or accelerate the launch of future clinical or translational osteosarcoma studies.
- Power analyses demonstrating the number of samples from patients needed to answer the desired biological question.
- Access to relevant clinically annotated samples or approval for prospective collection of samples sufficient to answer specifically articulated correlative study questions.
- Preliminary data demonstrating technical ability to apply desired technology for correlative analysis to relevant osteosarcoma biospecimens.
- For exploratory or hypothesis-generating studies, truly novel technologies not effectively used previously to study human osteosarcoma tissues.
Translational studies (up to $500,000 over two years) – Features of an optimal preclinical dataset for osteosarcoma metastasis drug development have been reported (Khanna et al, Clin Can Res 2014). Briefly, an ideal dataset would have the following features:
- a drug target demonstrated to be relevant in osteosarcoma, rigorously and mechanistically tested in multiple preclinical models across preclinical model species, and in human osteosarcoma cells and/or lesions
- the availability of a therapeutic candidate or drug suitable for preclinical studies and future human translation; a testable PD marker of effective drug exposure
- a correlative biomarker that may be translated to human patients in support of optimal dosing
Applicants are encouraged to describe how their proposal will contribute to the establishment of such a dataset, either by addressing existing gaps or otherwise.
For all Grant Categories
Funding will be based on the proposal and may be used to support any aspect of proposed studies. Indirect costs may not exceed 10%.
Note: The following application procedures and timeline constitute the primary OSI grantmaking cycle, which is the preferred method of applying to us for a grant. OSI recognizes that not all projects are compatible with these time restrictions; accordingly, we consider out-of-cycle proposals on a case-by-case basis. Contact us for information on making an out-of-cycle proposal.
Applications must be submitted through Proposal Central. Applicants should visit https://proposalcentral.com, create an account, if necessary, and login. Then, select the Grant Opportunities tab and enter “Osteosarcoma Institute” in the search box. The application form is available by clicking Apply Now on the appropriate line: Phase 2 Clinical Trial in Recurrent Osteosarcoma Patients, Correlative Science Supporting Clinical Studies, or Translational and Preclinical Research in Osteosarcoma.
- LOI proposals are due November 15, 2020
- LOI reviews will be completed and invitations to submit full proposals will be issued by January 15, 2021
- Full proposal submissions are due April 15, 2021
- Award announcements estimated June 2021
Published by the Osteosarcoma Institute on October 5, 2020.