Compassionate Use of Aldoxorubicin in Sarcoma Patients Chemotherapy

This is a compassionate use protocol allowing sarcoma patients that have relapsed after
prior therapies and are not eligible for other protocols involving the evaluation of
aldoxorubicin to receive aldoxorubicin.

Inclusion Criteria:

- Metastatic or unrectable sarcoma that has either relapsed or was refractory to at
leat 1 prior chemotherapy or immunotherapy regimen and for which no standard approved
therapy exists

- Must not be eligible for another CytRx-sponsored clinical trial

- Able to provide complete medical records for review by the CytRx Medical Monitor

- Able to receive treatment at a site that is participating or has participated in
another CytRx-sponsored aldoxorubicin trial

- Capable of providing informed consent and complying with trial procedures

- ECOG performance status 0-2

- Measurable or evaluable tumor lesions according to RECIST 1.1 criteria

- Women must not be able to become pregnant (eg post-menopausal for at least 1 year,
surgically sterile, or practicing adequate birth control methods) for the duration of
the study

- Women of child bearing potential must have a negative serum or urine pregnancy test
at the Screening Visit and be non-lactating

Exclusion Criteria:

- Chemotherapy, palliative surgery and/or radiation treatment less than 30 days prior
to screening for non-target lesion

- Exposure to any investigational agent within 30 days of screening

- Central nervous system metastases that are symptomatic

- Laboratory values: Screening serum creatinine >1.5×ULN, ALT >3×ULN, or >5×ULN if
liver metastases are present, total bilirubin >3×ULN, ANC <1,500/mm3, platelet
concentration <100,000/mm3, hematocrit level <25% for females or <27% for males,
coagulation tests (PT, PTT, INR) >1.5×ULN

- Anion gap > 16 meq/L or arterial or venous blood pH < 7.30.

- Clinically evident congestive heart failure > class II of the New York Heart
Association (NYHA) guidelines

- Current serious, clinically significant cardiac arrhythmias, defined as the existence
of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V

- Baseline QTc >470 msec and/or previous history of QT prolongation while taking other
medications. Concomitant use of medications associated with a high incidence of QT
prolongation is not allowed

- History or signs of active coronary artery disease with or without angina pectoris.

- Serious myocardial dysfunction defined scintigraphically (eg MUGA, myocardial
scintigram) or ultrasound determined absolute LVEF <45% of predicted

- History of HIV infection

- Active, clinically signifiant serious infection requiring treatment with antibiotics,
anti-virals or anti-fungals

- Major surgery within 3 weeks prior to enrollment

- Substance abuse or any condition that might interfere with the subject's
participation in the study or in the evaluation of the study results